TGA changes continue to impact and sometimes baffle pharmacists

A number of recent decisions by the Therapeutic Goods Administration (TGA) are highly relevant to pharmacists in Australia. Firstly, the interim decision from the November 2017 Advisory Committee on Medicines Scheduling (ACMS) to continue to allow general sale (outside of pharmacy) of ibuprofen of up to 25 units of 200mg of ibuprofen would concern most pharmacists who understand the risks with the use of ibuprofen.

This is especially relevant for patients with conditions such as cardiovascular disease, renal disease, gastrointestinal issues or asthma.

PSA recommended ibuprofen be up-scheduled, as proposed, so that over-the-counter availability of ibuprofen-containing products was restricted to a pharmacy setting. We believed this provided the opportunity for pharmacist intervention, supported a Quality Use of Medicines (QUM) approach to the use of ibuprofen and would enhance patient care overall. On the back of the recent up-scheduling of codeine, we certainly believed this provided a level of consistency in the risk management approach by the ACMS to the scheduling of medicines.

The Australian Commission on Safety and Quality in Healthcare in their National Statement on Health Literacy said: ‘Only about 40% of adults have the level of individual health literacy needed to meet the complex demands of everyday life’. The statement goes on to say: ‘This means, for example, that only about 40% of adults can perform tasks such as combining information in text and a graph to correctly assess the safety of a product. It means that only 40% of adults can understand and follow health messages in the way in which they are usually presented. It also means that only about 40% of adults will be able to make good choices based on a thorough understanding of the issues they face and the choices available’.

I therefore seriously struggle to understand how labelling and packaging requirements for ibuprofen can suffice, without the availability of the advice of a pharmacist who can tailor the information based on the health literacy of the patient, in ensuring the safety and effective use of ibuprofen. In addition, it is known that many users of OTC ibuprofen exceed the recommended maximum daily dosage.

Of concern, there is now accumulating evidence that taking ibuprofen regularly, in any dose, quickly increases the risk of having an acute myocardial infarction (AMI; by about 25-50%).¹ Research published in the BMJ in 2017, noted that there was an increased risk of AMI in patients taking >1200mg daily of ibuprofen for short-term use (generally between 1-4 weeks use) and also in patients who were taking <1200mg daily for greater than one month continuously. Use of even low doses for greater than one month increased the AMI risk by 32%. Similarly, a Danish study² 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%).

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.’ The European Society of Cardiology Working Group in Cardiovascular Pharmacotherapy has published a position paper³ with their recommendations including: 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 this information underlines 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. Without the advice of a pharmacist, use outside of the labelling requirements and warnings is very likely, especially in open-sale environments. Consistency must also be shown in this decision making process.

PSA is also involved in a TGA Scheduling Working Group which is focussed on establishing a new appendix in the Poisons Standard to enable additional controls or requirements for S3 substances.

What this means is that there may be additional medicines that are down-scheduled into Schedule 3 but that have additional requirements, which a pharmacist must comply with, to be able to provide those medicines. PSA firmly believes these additional controls are a matter for the profession to develop, implement and monitor. While the TGA may broadly specify the nature of the additional controls, such as training and/or certification, supply according to protocol, recording and privacy requirements, PSA, as the standards setting body for the profession, must be responsible for developing, implementing and monitoring this professional framework for additional controls for scheduled medicines.

Members will have also seen that there are to be S3 advertising reforms – the default position by the TGA has been revised to allow S3 substances to be advertised unless the scheduling delegate determines they should not be. PSA, as part of the Scheduling Working Group, will provide advice to the TGA about substances currently in S3 and their suitability for advertising. We will also be focussed on providing input into the factors for determining suitability for default advertising, ensuring that the public is fully informed about the suitability of the medicine for a given condition and that the vital role of the pharmacist in ensuring appropriateness of the S3 medicine is maintained. Be assured here that public safety is paramount, and medicines that are at high risk of abuse or misuse will not be supported for advertising by the PSA.

Members will have also seen discussion about permitted indications for listed medicines sponsors on the Australian Register of Therapeutic Goods (ARTG), and this is applicable to complementary and alternative medicines.

Pharmacists rely on the regulator, and in this case the TGA, to have a robust assessment method for establishing therapeutic claims.

The focus on this was to reduce the risk of consumers being misled by industry claims about the therapeutic effectiveness of products. I am sure that allowing outlandish claims such as “moisten dryness in the triple burner” and “softening hardness” are baffling to any health professional, and do not help pharmacists deal adequately with the consumer demand for complementary and alternative medicines, and ensuring their safe and effective use.

References

1. Bally M, Dendukuri N, Rich B, et al. Risk of acute myocardial infarction with NSAIDs in real world use: bayesian meta-analysis of individual patient data. BMJ 2017;357:j1909.l
2. Sondergaard K, Weeke P, Wissenberg M, 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. European Heart Journal 2017;3(1):100-107.
3. Schmidt M, Lamberts M, Olsen A, 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. European Heart Journal 2016;2(1):108-118.