Nurofen is the brand name of at least eleven varieties of pain-relief medication made by Reckitt Benckiser and introduced in Australian over the counter (OTC) market in October 2002. Nurofen Plus in tablet form contains 200 mg ibuprofen and 12.8 mg codeine phosphate. For some time, it is considered as one of the leading codeine tablet available without prescription within Australia. Nurofen Plus is used primarily as pain reliever for toothache and other ailments like menstrual pain, back ache, fever or headache.
For many years, authorities had not considered Nurofen Plus harmful until the alarming rise for its demand in 2007 and the death of a British woman, Linda Docherty, 49 in March after taking up to 64 tablets per day of Nurofen Plus for two years (Article: The Age on April 15, 2008). The rise of hospital incidence for cases related to codeine misuse pointed also posible misuse of the drug.
In the same year, Codeine Phosphate paracetamol 30mg/500mg and Diazepam 5mg tablets were strongly associated with the spike in doctor shopping (DCPC, 2007 Anex, 2011), the phenomenon of those addicted to the drug shopping for doctors who will readily prescribe it. This significant demand for Nurofen Plus caught the attention of the Australian Government’s National Drugs and Poisons Schedule Committee (NDPSC). Incidental to this, was the practice of some doctors who were administering methadone to help patients rid themselves of Nurofen Plus addiction.
The dangers associated with Nurofen
Previously, Nurofen Plus was available in OTC packs of up to 72 tablets, but of course that number can grow considerably when purchased online. Its active ingredient, ibuprofen is a non-steroidal anti-inflammatory agent which can cause ulcers in the stomach and duodenum.
Patients taking Nurofen Plus were found to suffer severe hypokalaemia secondary to ibuprofen-induced renal tubule acidosis while some patients taking high-dose of OTC drugs of non-aspirin, non-steroidal, anti-inflammatory drugs suffered acute upper gastrointestinal presentations. This allegedly can be fatal when it resulted to liver toxicity and gastric haemorrhage, according to reports from SUSDP – Poison Standard 2011 – Department of Health and Ageing.
Codeine in Nurofen
Nurofen Plus also contains codeine. Codeine is a narcotic analgesic that can be extracted from opium. Although it is less potent and less addictive than in morphine, but it is one of the most widely used naturally occurring drugs in medicine today. In some instance, it is available in an injectable solution for pain management. It is also an effective cough suppressant and one of the common component in cough syrups.
Morphine, codeine, pethidine and methadone belong to the group of drugs known as opioids, or narcotic analgesics. The drugs can either be naturally occurring (opiates) or synthetic derivatives (opioids) of opium. Opiates have strong pain-killing capabilities. Nurofen Plus contains codeine a weaker form of opioid. However, codeine as an ophiod can lead to problems of tolerance and drug dependence when administered for long period of time. As per reports, persons addicted to codeine may be taking as many as 24 to 80 tablets a day of Nurofen Plus.
In 2007, around 7,000 Australians had joined an online forum claiming they have or currently were addicted to Nurofen Plus. Likewise, Pharmacists have reported on significant requests for codeine-combined painkillers.
Alarming rise for Misuse of OTC drugs
Study shows that Nurofen Plus is prone to misuse because of its high codeine content and the absence of toxicity in overdose normally associated with paracetamol preparations. After prolonged use Nurofen Plus, patients were found to suffer severe hypokalaemia secondary to ibuprofen-induced renal tubule acidosis. Another study showed that patients with acute upper gastrointestinal presentations had taken a high-dose of OTC drugs of non-aspirin, non-steroidal, anti-inflammatory drugs origin for the past weeks.
Government action to Nurofen Plus
For fear of growing codeine abuse, the Australian National Drugs and Poisons Scheduling Committee (NDPSC) has decided to examine the scheduling of Nurofen Plus, including, whether a schedule 8 listing is necessary, Prior to 2010, Nurofen Plus was not among the drugs included under Schedule 8 (controlled substances) of the Standard for the Uniform Scheduling of Medicines and Poisons in Australia. Schedule 8 is a restricted category for drugs that are highly addictive and potential for drug abuse.
In response, Dr. John Gullotta from the Australian Medical Association stated that making the drugs (Nurofen Plus) prescription only would be an extreme move. “Schedule 8 is usually reserved for medications that have been abused while they’re on prescription, and these medications aren’t even on prescription right now,” he said. However, some socialists suggested limiting codeine content in OTC in pack sizes and reducing advertising campaign as more appropriate alternatives to rescheduling.
What are included in Schedule 8 (controlled substances)?
In Australia, it is the Drugs and Poisons Schedule Committee of the National Health and Medical Research Council (NHMRC) that will provide Schedules (drug category) in the National Standard for the Uniform Scheduling of Medicines and Poisons to promote uniformity of schedules all throughout Australia.
Today, it is a must that codeine preparations are only sold in legitimate pharmacies with the assistance of pharmacists. Preparations will often be a combination of paracetamol (500 mg), ibuprofen (200 mg) and doxylamine succinate (5 mg) and the codeine content may range from 5 mg to 15 mg.
Preparations in excess of 30 mg per tablet are included in Schedule 4 or (Prescription Only) category. Whereas, preparations that contain pure codeine (codeine phosphate tablets or codeine phosphate linctus) will be available by prescription only. This will be included in Schedule 8 (Controlled Drugs) and makes possession without authority as illegal.
Included in Schedule 8 are Morphine, Amphetamine, Cocaine, Barbiturates, methadone, stimulant medication and some sedatives among others which are available only on prescription and with stringent requirement for records of patients.
In Northern Territory, they adopted the scheduling of drugs under the Standard for the Uniform Scheduling of Medicines and Poisons in Australia and defined Schedule 8 as: substances that should be available for use but require restrictions relating to manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence. It is also further classified as Dangerous Drugs.
Schedule 8 requirements
Schedule 8 preparations are subject to regulations of all medications available to the public. Its availability is subject to some restrictions based on supply, manufacture, distribution, possession and use to reduce abuse, misuse and prevent physical or psychological dependence.
Section 8 drugs are governed by the strict prescription guidelines and storage practices under the Drugs, Poisons and Controlled Substances Regulations 2006 which include the following:
– It is a prescription drug. A drug that requires medical prescription before it can be obtained.
– Doctors must have a schedule 8 permit. Before a health care practitioner can prescribed S8 medicines, the doctor must obtain a valid license granting authority to prescribed S8 medicines
– It is illegal to possess Schedule 8 drugs. Unless, you are the person who has been prescribed to use the drug, it is illegal to possess S8 medicines.
– Records of patients for S8 medicines must be kept for 3 years. A pharmacist must also be involved at every sale to record the customer’s details whose records must be preserved for 3 years.
– S8 drugs must be packed in smaller doses. Nurofen Plus will now be packed in smaller sizes and with smaller doses of codeine. Each pack will only contain 30 tablets in a six per day pack and 40 tablets in an eight per day pack.
– Prescription must only be for a period of three months.
– S8 drugs must be stored or kept in cabinets.
What’s happening now!
According to the Pharmacy Guild of Australia, the changes in scheduling would pose inconvenience to the majority of Australians who use the painkillers appropriately. Whether the move will deter the acquisition of drugs containing codeine for non medical uses remains to be seen. As of this moment, the fact remains that acquisition of Nurofen Plus and other drugs by illegal means is still rampant. Experts believed that the stricter purchasing conditions under Schedule 8 will not stop addicts from resorting to illegal means.