I’ve got 99 problems… and codeine is one

Results of a new study on the cost of OTC codeine informed the TGA in its upscheduling decision – but Guild says there is more to the story

Researchers from South Australia have conducted the largest known examination of hospital admissions relating to use of OTC combination analgesics containing codeine.

Admissions related to prescription codeine products were excluded from the study, as well as those related to polypharmacy overdose and intentional paracetamol/aspirin/ibuprofen overdose.

The researchers reviewed discharge summaries of more than 1000 patients admitted to Flinders Medical Centre in South Australia between June 2010 and June 2015 for specific drug-related conditions, and determined 99 hospital admissions across 30 individual patients were eligible for the study.

The mean consumption across the sample was 28 OTC codeine tablets per day, with the highest level of ingestion reaching 90 tablets per day.

Duration of patient-reported OTC codeine use ranged from a few days to 10 years, with a mean of 606 days prior to admission.

Among eligible patients, 70% reported use of ibuprofen/codeine products, 21% reported use of paracetamol/codeine products, and 9% used both.

No patient reported use of aspirin/codeine products.

The most commonly reported indication for OTC codeine use was musculoskeletal pain (26.7%), followed by headache/migraine (13.3%).

Altogether the 99 OTC codeine-related hospital admissions were estimated to cost the local healthcare system a total of $1,008,082 – leading to a mean of $10,183 per hospital admission.

The study authors point out that OTC use and dependence was poorly documented by clinicians, and where dependence had not been identified on admission, a mean of 4.8 days had elapsed before identification.

“This study was designed to help inform discussion around the costs of OTC vs prescription access to low-dose codeine containing analgesics,” says study co-author Jacinta Johnson, Senior Pharmacist and Clinical Educator at Flinders Medical Centre, SA Pharmacy and SA Health.

“Our findings were provided to the TGA prior to their decision late last year,” she tells AJP.

“As the rescheduling decision has now been made, we hope that by quantifying some of the costs associated with over-reliance on analgesics to manage chronic pain, this study will highlight the need to invest in greater comprehensive, multidisciplinary pain management services.

“Additionally, we hope that summarising the features of these presentations will help clinicians to identify patients who are overusing these products sooner.”

Dr Johnson says the results add to the body of evidence describing the harms associated with OTC codeine products.

“Given there is only limited evidence to show adding low-dose codeine to simple analgesics provides a benefit over simple analgesics alone, to me the overall harms outweigh the benefits,” she argues.

“Regardless of how such products are accessed – over the counter or via prescription – there will always be potential for misuse and pharmacists have a vital role to play in educating patients and monitoring pain management over time.”

“There needs to be some clarity”

Victorian pharmacist Jarrod McMaugh agrees but thinks there is more to the story.

“The impact of misuse of any medication (regardless of schedule) is a concern for all health professionals,” he says.

“Despite this, there needs to be some clarity on the way in which people are ending up in hospital with these serious outcomes.

“When an adverse outcome occurs in a patient who is taking OTC medication, a disproportionate weight of importance is put on this without due consideration of the impact of prescription-only medication, or whether the medication was accessed via a prescription.

“For instance, the TGA decision to alter the scheduling of codeine noted that there were significant harms associated with use of OTC codeine without discussion of concomitant opioids or whether any of the patients harmed by codeine use were regularly reviewed by a GP or pain specialist,” Mr McMaugh tells AJP.

“When I refer to my own dispensing records since August (all codeine dispensing is recorded in my pharmacy) for 163 patients, 60% had prescriptions for combination codeine products. Of the remaining 65 patients, 42 had a single purchase of OTC codeine, and the remaining 23 had both OTC and prescription-only codeine products. Interestingly, patients who had prescribed codeine included a large number of privately prescribed OTC-strength products.

“The $1 million over five years identified in the study may sound like a significant sum, but it pales alongside the estimated $266 million a year minimum … the codeine scheduling decision will cost our health system,” says the Guild.

“I think that the wider health community is not acknowledging that access to ‘OTC’ codeine occurs via prescriptions, and those patients who are consuming opioids in the volumes that lead to hospitalisation are not restricting their access to OTC purchases. They doctor-shop and obtain prescriptions for various opioids, including OTC-strength products.

“Given that the research discusses in some depth the impact of ‘open access’ to codeine, it is important that the research quantitatively determines the source of the opioids that lead to harm.

“These concepts are important to consider in the impact of the TGA’s decision on access to codeine, and whether the decision has lead to improved outcomes and reduced harms. It could certainly be argued that without real time monitoring, the impact of scheduling alone will not minimise harm, and may potentially increase it due to prescribing cascade and dose escalation.”

$1 million… or $266 million?

The Pharmacy Guild of Australia maintains that most codeine-related fatalities are not from OTC codeine medicines.

“The plight of patients who become addicted to medicines containing codeine is of serious concern to the Guild and to all health professionals,” says a spokesperson for the Pharmacy Guild.

“The Guild has for many years been at the forefront of advocating for and taking action to introduce tools that enable clinicians to identify and support patients at risk of dependence.

“The people who become addicted to over the counter codeine and cause self-harm through overuse are a very small minority of the Australian consumers who use these medicines safely and appropriately,” they tell AJP.

“Furthermore, most codeine-related fatalities are not from OTC codeine medicines. The majority are a result of high-strength medicines that are prescribed by doctors and/or as a result of combination of medicines consumed by patients. Nevertheless, it is imperative that better systems are put in place to try to prevent such abuse of over-the-counter products, and the associated harm and cost.

“With mandatory national real-time recording of sales of medicines containing codeine, the likelihood of a patient being able to purchase and consume up to 90 tablets a day would be vastly reduced.”

The Guild says that under its proposed mandatory real time monitoring system, it is more likely that a person overusing codeine medicines would be detected, counsellor and either referred to their GP or into drug addiction and pain management support.

“The upscheduling of these medicines alone will not prevent abuse, especially while there is no real time national recording mechanism in place for doctor prescriptions. Doctor shopping is a reality, which doctor groups appear helpless or disinclined to combat.

“As to cost – the $1 million over five years identified in the study may sound like a significant sum, but it pales alongside the estimated $266 million a year minimum in additional health system costs (including additional doctor visits) that the codeine scheduling decision will cost our health system,” says the Guild spokesperson, referring to a Cadence Economics report prepared for the Pharmacy Guild in November 2015.

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