It may soon be much harder to get one’s hands on the common over-the-counter pain drug codeine if the Medicines Control Council has its way.
The council wants to make the potentially addictive medicine harder to get without a prescription because of “the high abuse potential of codeine-containing products”, it said in draft regulations published earlier this year and for which the public comment process ended in September.
If the council decides to change its regulations, popular pain, flu and cough mixture products like Myprodol, Benilyn C and Sinutab C would have to alter their formulations to contain less codeine. And some schedule two products would move to the highest scheduling status, schedule six.
Codeine belongs to the family of opiates, which include morphine and heroin, and gives the user a sense of euphoria if taken in high enough doses, according to the Global Information Network About Drugs.
Combination productsBut, according to David Beyever, from the University of the Witwatersrand’s pharmacy department, the strength of codeine in combination products “should not present a problem” in terms of addiction if taken at the recommended dose. He said people were at risk of becoming dependent on the pain killer when they bought a number of codeine-containing products and used them concurrently, usually without realising they were taking too much codeine.
Beyever also said that individuals metabolised codeine at different speeds and some people felt the effects of codeine more intensely than others and were therefore at a higher risk of becoming addicted than others. Needing increasing quantities of the medication to achieve the same effect is a sign that one is dependent or addicted.
Although there are no reliable statistics on codeine addiction in the country, a 2010 report published by the International Narcotics Control Board singled out South Africa for its high consumption of codeine. It used sales data from pharmaceutical companies to calculate the average amount of codeine consumed in individual countries; South Africa used more of the medicine than any other country on the continent and ranked 49 out of 193 countries globally.
High abuse potential The council’s Shabir Banoo said these changes were prompted by concerns about the high abuse potential of codeine and the need to keep abreast of global restrictions in the use of the drug. He said the new schedules will limit “the maximum daily dosage in over-the-counter products to 80mg and the maximum treatment period to five days” and will be published next year.
The council’s proposed “up-scheduling” of codeine has met resistance from many experts in the field.
Johann Kruger, president of the Pharmaceutical Society of South Africa, said: “In my personal opinion this move is an exercise in futility.”
He argued that people with a dependence on codeine would still find ways to get it through “doctor and pharmacy shopping” – when a patient visits different doctors or fill prescriptions at different pharmacies to avoid suspicion.
“In the current system, when codeine-containing medications are purchased, a patient’s name and address are recorded as a way of tracking and preventing abuse,” he said.
But all pharmacies have their own system or database and a pharmacist cannot tell whether a patient is also visiting other pharmacies.
Data to back decisions “Under South African law, a pharmacist can refuse to dispense a medication to a patient if he or she suspects they are abusing it. A pharmacist struggles to make this decision because he doesn’t have all the data to back it up,” said Kruger.
He maintained that if the council lowered the dose in over-the-counter products, a codeine abuser would simply buy two packs instead of one, probably from two pharmacies – with each none the wiser.
He said that the council’s proposed regulations would only result in lost money and time and have no beneficial impact on patients with dependency problems.
“All the drug manufacturers will have to change their dosage and packaging, which will cost huge amounts of money, and nothing will be done for the patient at the end of the day.”
Initiative to track useHe argued that the Codeine Care Initiative, a project started by the Pharmaceutical Society in January, for which he is the spokesperson, is a more efficient way of tracking use and helping patients.
The initiative involves recording codeine purchases and patient ID numbers on a central database to avoid duplication. If a person is seen to have bought more than 4.2g of codeine in a month, the equvalent of 14 Myprodol tablets a day, he or she is flagged by the software.
“It’s up to the pharmacist to decide what to do next. He can alert the patient to the problem, educate him and refer him to a rehabilitation centre if necessary,” said Kruger.
He argued that the person would not be prosecuted. The most severe repercussions would be that he or she would not be sold codeine-containing drugs, but this is at the discretion of the pharmacist.
System could work for other drugsThe Codeine Care Initiative is a way to track codeine use and get a better idea of whether codeine addiction is as big a problem as has been suggested by the relatively high consumption revealed by the International Narcotics Control Board.
So far just over 200 pharmacies are involved in the initiative, including all 72 Netcare Hospital pharmacies and a number of smaller groups and independents. A “significant number” of “red flags” were already being picked up, said Kruger.
The big pharmacy chains, Clicks and Dis-Chem, have expressed interest but were hesitant to join, according to Kruger. He said they worry about losing business if customers didn’t want their details recorded.
“Once we’ve proved that this system works, it can be used as a tool by legislators and professionals to track other substances of abuse like sleeping tablets,” Kruger said.“All the drug manufacturers will have to change their dosage and packaging, which will cost huge amounts of money and nothing will be done for the patient.”
Codeine is an opiate drug derived from poppies and is mainly used for pain relief, but in large doses it can produce a feeling of euphoria, which makes it a popular substance to abuse, according to the Global Information Network About Drugs (Ginad). It can also become highly addictive and dependent users suffer withdrawal symptoms when they stop.
In South Africa, codeine is available without prescription in a number of over-the-counter products including combination pain killers, cough syrups and antihistamines, according to Andy Gray from the University of KwaZulu-Natal’s pharmacy department.
Taken in large enough doses, especially in conjunction with alcohol, there can be potentially dangerous side effects including depression, nausea, drowsiness, headaches and, in some cases, prolonged use can result in liver and kidney damage, according to Ginad.
“In an overdose, the immediate problem is respiratory depression, which can be fatal,” said Gray. “With dependence, a patient will experience withdrawal symptoms (anxiety, sweating, palpitations) unless a dose is ingested.”
Dependent people would need higher and higher doses to attain the same effects. “It is difficult to predict who can become addicted to the drug because codeine is metabolised differently in different people.”
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