A side effect to the upschedule

With codeine-containing medicines going to prescription-only, has the time come to again restrict the sale of all ibuprofen products to pharmacies?

Ron Batagol, PhC,FSHP,AGIA, Dip.Jnl.
Pharmacist and Obstetric Medication and Medication Safety Consultant

Professor Gregory Peterson BPharm (Hons), PhD, MBA, FSHP, FACP, FPS, AACPA, ARPharmS, GAICD
Co-Director – Health Services Innovation Tasmania (HSI Tas) and Professor of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania

After the sound and fury of the various debates from all and sundry on the upcoming restriction of codeine combination analgesics to supply by prescription only, and with the clock rapidly ticking towards the 1st of February, there is an important medication safety issue to consider in this scenario.

After codeine combination products go to S4 and are unavailable OTC from pharmacies, ibuprofen, with or without paracetamol, is likely to be the mainstay of non-prescription pain relief options.

However, we do have to ask the question – have the authorities overlooked the proverbial elephant in the room here?

Because, if ibuprofen continues to remain available for sale in supermarkets and other outlets, as it has been since 2003, consumers who may have been purchasing codeine products from pharmacies, may, in line with the Australian community trend identified in a recent study by Mortimer,1 increasingly seek to self-select and purchase ibuprofen products from supermarkets as an alternative to codeine, without utilising the professional advice and guidance of a pharmacist.

In purchasing ibuprofen at supermarkets (or other general stores), without pharmacist guidance and advice, any of these patients who have an underlying susceptibility to cardiac or renal adverse events may unwittingly place themselves at risk of such an adverse event.

In October 2017, we responded to a TGA request for public comments on the option of removing the exemption allowing supermarkets general stores to sell ibuprofen. The following is a brief summary of the key points of our submission, endorsing this proposal to restrict all sales of ibuprofen to pharmacy outlets:

1. Patterns of antihypertensive medication management have changed since 2003, when the exemption was given to sale of ibuprofen in general stores.

In 2003 and again in 2006,2,3 the then Adverse Drug Reactions Advisory Committee (ADRAC) issued warnings about the severe adverse health outcomes, including acute renal failure, that can and did arise in patients who were prescribed an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) medication with a diuretic, and then also took a non-steroidal anti-inflammatory (NSAID) product – the “triple whammy effect”, resulting from reduced renal blood flow.

This concern was also endorsed by other medical experts.4

In this context, it is very relevant to emphasise the relatively new and increasing pattern of use of combination products containing  either an ACE inhibitor or ARB plus a diuretic, for hypertension (two out of three ready-made “triple whammy” components!), which can result in an increased potential risk of  “triple whammy” renal adverse events.

2. Recently, there has been a greater use of antithrombotic drugs to reduce the risk of stroke in atrial fibrillation; the co-administration of these drugs with NSAIDs can result in major bleeding events.5,6

Again, this especially poses a risk for consumers who self-select the NSAID treatment and purchase these products from a general store, without the benefit of health professional screening and advice.

3. Perhaps most importantly, much more information is now available on the risks associated with NSAID use, particularly related to cardiovascular events.

For instance, there is now evidence that taking ibuprofen regularly, in any dose, quickly increases the risk of myocardial infarction (by about 25-50%).7  The increased risk appears to occur within the first week of regular use.

Similarly, a Danish study recently found that short-term treatment with non-selective NSAIDs, particularly ibuprofen and diclofenac, was associated with an increased early risk of cardiac arrest (by about 30%).8

The lead investigator of the latter study called the findings a “stark reminder that NSAIDs are not harmless” and said “ibuprofen and similar drugs should only be sold in pharmacies, in limited quantities and in low doses.

“Allowing these drugs to be purchased without a prescription, and without any advice or restrictions, sends a message to the public that they must be safe.

“NSAIDs should be used with caution and for a valid indication. They should probably be avoided in patients with cardiovascular disease or many cardiovascular risk factors. I don’t think these drugs should be sold in supermarkets or petrol stations where there is no professional advice on how to use them.”9

The European Society of Cardiology Working Group in Cardiovascular Pharmacotherapy has published a position paper, with their recommendations including:10 

  • Non-aspirin NSAIDs should only be sold over the counter when measures are put in place to ensure that their use is accompanied by an appropriate warning of their frequent cardiovascular complications; and
  • Non-aspirin NSAIDs should in general not be used in patients with established or at high risk of cardiovascular disease.

All of these factors underline the importance of the need for appropriate professional guidance for NSAID therapy in the general population, including counselling and professional advice for OTC sales of NSAIDs.

Changes to the availability of codeine-containing products should reduce misuse, addiction and overdoses.

Now, all we need is the appropriate legislative change of pharmacy-only supply of ibuprofen, to ensure that patients who are at risk of adverse outcomes from using these products are in a position to minimise that risk by seeking professional advice and guidance from their community pharmacist!


1. Mortimer G. Examining the impact of trust and perceived risk on purchase intentions of unscheduled medicines in supermarkets. J Pharm Pract Res 2017 doi: 10.1002/jppr.1359.

2. Anon: ACE Inhibitor, diuretic and NSAID: a dangerous combination. Adverse Drug Reactions Bulletin 2003;22(4):14-15.

3. Beware the triple whammy. Adverse Drug Reactions Bulletin 2006;25(5):18.

4. Call to extend NSAID warnings. MJA Insight 2014;37(6).

5. Di Nisio M et al. Risk of major bleeding in patients with venous thrombosis treated with rivaroxaban or with heparin and vitamin K antagonists. Thromb Haemos 2016;115(2):424-32.

6. Mavrakanas TA et al. Direct oral anticoagulants: efficacy and safety in patient groups. Swiss Med Wkly 2015;145:w14081.

7. Bally M et al. Risk of acute myocardial infarction with NSAIDs in real world use: bayesian meta-analysis of individual patient data. BMJ 2017;357 doi: 10.1136/bmj.j1909.

8. Sondergaard KB et al. Non-steroidal anti-inflammatory drug use is associated with increased risk of out-of-hospital cardiac arrest: a nationwide case-time-control study. Eur Heart J Cardiovasc Pharmacother 2017;3(2):100-07.

9. http://www.independent.co.uk/life-style/health-and-families/health-news/ibuprofen-cardiac-arrest-risk-sales-restriction-painkiller-study-a7631561.html

10. Schmidt M et al. Cardiovascular safety of non-aspirin non-steroidal anti-inflammatory drugs: review and position paper by the working group for Cardiovascular Pharmacotherapy of the European Society of Cardiology. Eur Heart J Cardiovasc Pharmacother 2016;2(2):108-18.

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  1. Debbie Rigby

    Yes, couldn’t agree more. Just like OTC codeine doesn’t meet
    requirements for scheduling S2 or S3, nor does NSAIDs un-scheduled –
    should only be in pharmacies under the direction of a pharmacist.

  2. Nicholas Logan

    Scheduling OTC ibuprofen would definitely save more lives than will up-scheduling OTC codeine combos.

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