The pros and cons of prescription-only liquid nicotine

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On October 1, domestic and international purchases of liquid nicotine, including products containing liquid nicotine, will require a prescription. This is the result of the Therapeutic Goods Administration (TGA) amending the poison control standard for nicotine.

But, in reality, not much has changed.

Consumers will no longer need to buy these products from dubious retailers. Image: Getty Images

It is currently illegal to sell and possess liquid nicotine in almost all Australian states and territories. Legal access requires an import under the TGA Personal Import Regime and, therefore, a medical prescription.

Nonetheless, there are several public health implications, both positive and negative, to the TGA’s decision.

Advantages

First, these changes to nicotine programming will allow consumers with a valid prescription to obtain nicotine vaping products (NVPs) – like e-cigarettes – nationally from local Australian pharmacies and online. .

Consumers will no longer need to buy products from questionable retailers or import products that may not be subject to good manufacturing practice standards.

These programming changes will allow nationally controlled access to NVPs while ensuring that NVPs sold in Australia meet basic requirements.

Second, the requirement for a prescription is an opportunity to ensure that smokers receive evidence-based smoking cessation advice from their doctor. A doctor can facilitate the use of a multi-session behavioral intervention (such as smoking cessation counseling) combined with drug therapy (if clinically appropriate), to maximize the chance of long-term success.

Flavored e-liquids, even those that claim to not contain nicotine, are toxic and harmful to health. Photo: Getty Images

It is important to ensure that smokers receive a multi-session behavioral intervention – offered by Quitline – as the few clinical trials demonstrating the effectiveness of NVP to date have included the use of a behavioral intervention.

Finally, although it is illegal to import NVPs like non-prescription e-cigarettes, thousands of products are imported this way, including by owners of tobacco, vaping and convenience stores who then resell these products. illegally.

Data released by NSW Health shows a substantial increase in seizures of illegal products over the past 18 months:

It is currently difficult for the Australian Border Force to confiscate illegal imports of nicotine, as nicotine is in two different TGA programs, one requiring the importer to have an order and the other not.

The TGA ruling means that a prescription is required for all imports of liquid nicotine. From October 1, any product entering the country without an associated prescription risks being seized at the border. This has the potential to reduce illegal importation and sale by opportunistic retailers.

The inconvenients

First, the decision to allow healthcare professionals to prescribe liquid nicotine sends a message that NVPs like electronic cigarettes are a legitimate smoking cessation aid and have therapeutic benefit.

This is not true. There is not enough evidence that NVPs are effective.

They are by no means a “quick fix”, although they are promoted as such. In fact, most smokers quit without help (that is, without any behavioral or pharmacological support).

In addition, clinical trials of e-cigarettes have found very high rates of continuous vaping, raising concerns that e-cigarette users will maintain their nicotine addiction long after quitting and are at increased risk of relapse.

Results from a large longitudinal study in the United States examining “real” NVP use suggest that nearly 40% of smokers who use NVP to quit smoking become “dual users” – using both NVPs. and cigarettes rather than quitting smoking altogether.

In addition, there are currently no TGA approved NVPs in the Australian Therapeutic Products Registry (ARTG).

Many NVP parts (including lithium batteries and problematic chargers) do not go through quality checks. Image: Getty Images

This means that the products currently sold and used have not undergone the strict testing procedures to which all drugs (including COVID-19 vaccines) are subjected, in order to assess their effectiveness, quality and safety.

TGA materials emphasize that these are not approved products. In contrast, nicotine replacement therapies such as patches, gums, and inhalers have been thoroughly tested and approved by the TGA.

We don’t want smokers to be turned away from effective and approved smoking cessation aids that have been rigorously tested.

It is essential that NVPs are not seen as “first line” approaches, but rather are only considered for smokers who have tried “first line” treatments without success.

Second, the TGA ruling does not affect nicotine-free vaping products like flavored e-liquids, and does not impose standards on vaping devices.

Evidence indicates that flavored e-liquids, even those that claim to not contain nicotine, are toxic and harmful to health. These flavors are also very appealing to young people, leading countries like Canada to restrict the promotion of the flavors.

In addition to this, the vaping devices available in Australia and abroad use a wide variety of interchangeable parts from different manufacturers. These parts (including lithium batteries and problematic chargers) are not subject to quality checks and therefore their safety cannot be guaranteed.

In Australia, the use of e-cigarettes among young people has tripled in the past six years. Image: Shutterstock

The vaping device (and its components) also affects the inhalation process, resulting in variable delivery of nicotine. Even the “safest” liquids can lead to poisoning if the device itself is improperly manufactured, maintained and used.

In terms of the concentration of nicotine in e-liquids, the TGA has not limited this as it has happened in other countries.

Australian consumers will be allowed to import nicotine up to a concentration of 100 mg / mL. This is more than five times the maximum allowed in Canada, the United Kingdom and throughout the European Union.

Third, there is the fact that although physicians have been able to prescribe NVP under the Personal Importation Scheme for several years, very few have.

The reluctance of physicians to prescribe is likely due to the unapproved nature of these products, as well as the lack of evidence that can be used to guide clinical judgment. At present, there are far too many unknowns for most physicians to feel comfortable prescribing NVP.

Fourth, the changes in nicotine planning do not mean that those who use NVP can or should do so forever. Much like patches, gums, and inhalers, NVPs should be a short-term approach.

However, the perception among consumers that e-cigarettes are less harmful than tobacco cigarettes (or worse, that they are harmless) can lead to long-term use of NVP because “what’s the harm if they quit? To smoke ” ? But the risks associated with using NVP extend beyond exposure to nicotine.

It is currently illegal to sell and possess liquid nicotine in almost all Australian states. Photo: Shutterstock

Finally, promoting NVP as a smoking cessation aid may lead to normalization of vaping and increased adoption among young people. Prevalence rates are already worrying, having risen dramatically in Australia and around the world.

In Australia, the use of e-cigarettes among young people has tripled in the past six years. In the United States and other countries, there has been an “epidemic” of e-cigarette use among young people.

Exposure to nicotine in adolescence and early adulthood affects brain development and can impact memory and concentration. In addition, there is growing evidence that electronic cigarette use acts as a “gateway” to smoking, especially among young people.

A recent report from Ireland shows that smoking rates among young people are on the rise – a finding that has been attributed to increasing use of e-cigarettes.

So where does that leave us?

While all the implications must be taken into account, it is essential that VPNs do not distract us from policy and practical interventions that we know reduce the prevalence of smoking.

The lack of action on evidence-based measures ranging from media campaigns to stronger supports for smokers, and how global tobacco companies are using the development of e-cigarettes and other new products to polish their image and present themselves as part of a “smoke-free world”.

During this time, their main activity continues to be the sale and promotion of cigarettes and other tobacco products.

Banner: Getty Images


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