Misuse of OTC Codeine: A Retrospective Study on Codeine Sales Data in Community Before and After Up-Scheduling
Back in February 2018, the Australian Therapeutic Goods Administration (TGA) made an announcement that Schedule 3(over-the-counter/OTC) codeine would be up-schedule to Schedule 4 (prescription-only). Prior to this up-scheduling, codeine was widely available as OTC analgesic in community pharmacies. This study aims to evaluate the benefits or harms of up-scheduling of codeine for everyone including health practitioners, patients, government and community in general. The objective of the study is to determine the use of codeine in the Australian community before and after up-scheduling by quantifying the extent of total codeine use. Codeine up-̉scheduling by TGA back in 2018 is thought to reduce the usage of codeine as it is not available OTC anymore, but the extent of the impact is uncertain. To compare, the national sales data (supplied by IMS Health) for codeine including prescription and OTC prior and post up scheduling are used to estimate codeine utilisation in the Australian community from 2015 to 2020. We expect to address the impact of this up-scheduling by seeing at least a slight decrease in a number of codeines dispensing and we can discuss any future research after the real-time monitoring (Safe Script) of codeine use goes mandatory in April 2020.
Keywords: codeine, up-scheduling, analgesic, over-the-counter
Codeine-containing products, usually combined with paracetamol was widely used globally for analgesia and guidelines generally address that codeine has a limited role in chronic pain management; however, it is recommended to be used in acute pain management prior to commencing stronger opioid (Therapeutic Guidelines, 2019). There is a decreasing trend in codeine manufacture since 2012, with global manufacture decreasing from 411.8 tones in 2012 to 281.5 tones in 2017. It is believed that certain warnings issued by various national organizations and regulatory bodies have been partly responsible for the decrease in manufacture (International Narcotics Control Board, 2019). One of such warning in Australia is up-scheduling of codeine from OTC to prescription-only.
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Codeine is often considered as a commonly misused medicine by community and Haggan’s (2019) studies have shown that thousands of Australians were taking codeine inappropriately. TGA has used the best available evidence to estimate that OTC codeine sales are associated with more than 100 deaths per year (TGA, 2018). In addition, Therapeutic Guidelines suggests that a lower dose of codeine (less than 30 mg 6-hourly) is no more effective than simple analgesia. National Prescribing Service (NPS) reaffirms that by recommending not to use OTC medication with sub-therapeutic doses of codeine for mild to moderate pain as there is evidence showing it only provide minimal benefit. Followed by evidence that alternative OTC analgesic such as ibuprofen was just as effective for short-term pain as low-dose codeine analgesia, but without the codeine-associated harm and dependence (NPS MedicineWise, 2017).
Given the rising trend of significant medical issues associated with addiction and misuse (Roxburgh, et al., 2015), the Australian government changed its regulation of codeine that is deemed by medical experts to have particular risks. Following up-scheduling in February 2018, access to codeine will now be based on the medical assessment of prescribing health care practitioners to eliminate any future codeine misuse. We therefore conduct a literature review on codeine use to evaluate the impact of up-scheduling on codeine usage.
From the analysis of pharmaceutical industry sales data released by TGA in 2018, the number of packs of codeine-containing products was approximately 50 percent lower than the annual average for the previous four years. Although the 2018 figure includes some data for OTC sales which is from the one month of sales before the up-scheduling, it is still a huge difference in the number being halved (Hawthorne ,2019). The TGA analysis shows that, for the first 11 months after up-scheduling, a total of 8524kg of codeine were sold. Estimating on past trends, had codeine still been available OTC, the amount of codeine supplied would have been 15,213kg, thus indicating that up-scheduling had resulted in a large decrease of codeine supplied to patients.
Currently, there is no Australian research demonstrating patterns of codeine utilization after its up-scheduling. It is difficult to obtain representative data quantifying the use of OTC codeine as codeine has weak drug regulation and poor record-keeping in pharmacies before up-scheduling (World Health Organization, 2003). Dispensing claim from the Pharmaceutical Benefits Scheme only include subsidised medicines so are not an accurate representation of codeine use across the entire community (Blanch, Pearson, & Haber, 2014). Aurora, et al (2013) studied codeine use using a convenience sample of people who self-report regularly inject codeine.
There is a need for a detailed and comprehensive analysis of the extent of codeine use in community incorporating both prescription and OTC codeine. Therefore, this study aims to examine the trend of use of codeine in the Australian community before and after up-regulation by quantifying the extent of total codeine. In this study, we analysed the impact of up-regulation of codeine to its usage as analgesia in a community setting.
This study will be a quantitative, retrospective study using data from pharmaceutical opioid sales data in Australia that requires a third-party access request approval from IMS Health, a provider of market intelligence to the pharmaceutical industry (Gisev et al., 2018). Comprehensive data, including all opioid purchases made through pharmaceutical wholesalers and manufacturers who sold directly to pharmacies well-documented in the sales data (Degenhardt, et al., 2016). This study focuses on codeine sold in all pharmacies in operation across Victoria between 2015 and 2020 and excluded codeine supplies in the hospital as there is no OTC codeine supplied in the hospital. Sales data (in pack sales and milligrams) from 2015 to 2020, would be extracted to compose a 6-year panel of data for analysis. All single-ingredient and combination prescription and OTC codeine analgesics available in Australia were included as the study population.
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All oral codeine available on prescription included 30 mg codeine tablets, 5 mg/mL codeine linctus, 30 mg codeine/500 mg paracetamol combinations and a 30 mg codeine/450 mg paracetamol/5 mg doxylamine combination. All OTC codeine available before up-scheduling included those available in combination with paracetamol (regular strength ≤10 mg codeine, higher strength 15 mg codeine, 1 mg/mL codeine liquid, a ≤10 mg codeine/≤500 mg paracetamol/5 mg doxylamine combination) and NSAID combinations (≤10 mg codeine combined with aspirin and ≤12.8 mg codeine combined with ibuprofen).By studying pharmaceutical codeine sales data, we can have a good representative codeine use across the entire community population, irrespective of PBS subsidisation (Gisev et al., 2018). The reason why we decide to not to do a qualitative study is that it is difficult to measure opinions to numerical date in terms of codeine usage through interviews or surveys.
Compared with before the introduction of codeine up-schedule, it is most likely that there is a decline in the total use of codeine in the Australian community….. As more patients who had been on OTC codeine is going to receive medical assessment with doctors while getting access to codeine. Their prescriber is likely to come up with a non-codeine specific analgesia management plan that is more appropriate for e.g. paracetamol-ibuprofen combination for mild analgesia. Most of them are likely to find it managed the pain as effective as codeine does (Haggan, 2019). It is also likely that there is a downtrend particularly in the sale of codeine with paracetamol combination and ibuprofen combination. This can reflect the limited role of low dose codeine in mild analgesia such as migraine. It is expected that there is no significant difference in codeine-only use, reflecting the effective role of codeine alone in chronic pain and cancer pain.
These data indicate the need for understanding patterns of codeine use. This could, in turn, be communicated to doctors to guide their clinical interventions aimed at reducing codeine-related harms. Through this research, we hope to generate strategies to optimise the use of codeine analgesics and optimise pain relief with minimal complications in general. We encourage further population-based studies exploring individual-level data on codeine use which could assess the safety of codeine through identifying risky prescribing patterns. It can also ensure all prescribers’ prescribing patterns are consistent with current health policy guidelines and limit concomitant use of codeine with other potentially high-risk medicines (Gisev et al., 2018).
This paper does rely on wholesale data and they are not without limitations. One of the main limitations of the dataset is the number of packs sold is not synonymous with the number of packs used. Our data is unable to estimate the number of people to whom these opioids were sold nor of the extent of utilisation per annum per person (Degenhardt, et al., 2016). It is difficult to obtain accurate and representative data sources to determine OTC codeine use in Australia as there are no mandatory requirements to record sales currently. However, Safe Script which is an electronic software that allows prescription records for codeine to be transmitted in real-time to a centralized database which can be accessed by doctors and pharmacists is going mandatory across Victoria in April 2020 (Department of Health & Human Services, 2018). Future studies examining trends in the rate of codeine dispensing using Safe Script are warranted to detect changes in use over time. There is still room for future research —-
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