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Harness the power to transform clinical development

Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.

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Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.

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Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.

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Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.

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"Global Trends in R&D 2024

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"DCTs Deliver Big ROI

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White Paper
Opiate of the Masses
Apr 11, 2018
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In response to rising codeine-related deaths, Australia’s Therapeutic Goods Administration (TGA) recently restricted access to the popular painkiller which can now only be obtained via prescription. This up-schedule represents a significant and rare disruption in both the OTC and pain markets. This report identifies key impacts and major shifts in the pain markets caused by the up-scheduling of codeine. 

Codeine is an old and popular opioid drug that relieves pain and suppresses coughing. In Australia, codeine is usually marketed in combination analgesics and cough-and-cold formulations. Until 2018, only products that contained more than 30 mg of codeine per dose were assigned to the S4 Poisons Schedule, where they were accessible through a prescription. Over-the-counter (OTC) products containing codeine were listed on the less restrictive pharmacy-only S3 or S2 schedule. These products typically contained 8 to 12 mg per dose and were always supplied in combination with other drugs, such as ibuprofen or paracetamol.

The availability of codeine without the requirement of a prescription has obvious benefits for the average consumer as it allows fast pain relief without a doctor’s intervention. However, new research suggests that low-doses of codeine (<30 mg), such as those found in OTC S3 and S2 products, are non-therapeutic and are no better at relieving pain than analogous products without codeine. This level of access further creates the potential for abuse and self-harm, which in extreme cases have led to death. Increasing mortality due to codeine abuse prompted the Therapeutic Goods Administration (TGA) to reschedule all codeine to at least S4, which took effect on the 1st of February, 2018.

This up-schedule represents a significant and rare disruption in both the OTC and pain markets. Observing and measuring the impacts the up-schedule will have on codeine use will be of critical importance to industry strategists, policymakers, and public health leaders.

We assessed the impacts the up-scheduling of codeine had on consumers, pharmacists, and manufacturers. We used our best-in-class data assets to study the distribution of non-prescription codeine products across Australia’s pharmacies, which allowed us to understand the commercial impacts of the TGA’s decision. We also used Channel DynamicsTM, which tracks pharmacist recalls of manufacturer promotional visits, to understand how promotional strategies to pharmacies have shifted. To find out how pharmacists prepared for the schedule change, we surveyed 200 pharmacists nationally as part of IQVIA’s monthly Medibus survey. This analysis was supplemented with a series of discussions with pharmacists in New South Wales, who were asked to provide their perspective on the expected impact of change on patient outcomes, opioid addiction, and their businesses.

In summary, we identified five key findings:
  • Harm from opioid abuse is increasing in Australia. Codeine related deaths were recently found to have doubled between 2000 and 2009.
  • The TGA estimates that up-scheduling codeine to prescription-only will result in $5.6 billion of net benefit over the next decade in the form of harm prevention, improved quality of life and a reduction in codeine long-term dependency.
  • OTC codeine sales declined in the months leading up to the up-schedule as ibuprofen-paracetamol combinations increased. Prescription-only codeine sales remain steady.
  • Manufacturers adjusted to the change by visiting pharmacies more frequently to discuss the schedule change. Manufacturers offered deals to pharmacies in an effort to clear OTC stock.
  • Pharmacies expect the up-schedule to negatively affect their revenue. They plan to use this opportunity to engage frequent and cyclical users on codeine-free pain management plans.

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