Among new recommendations are that e-cigarette products be registered and prescriptions limited to three months’ supply.
The AMA and RACGP are calling on the government to add nicotine vaping products to the Australian Register of Therapeutic Goods, with the AMA warning they should be “a last resort”.
The demands come in submissions earlier this week to the TGA’s public consultation on proposals to reform the regulation of nicotine vaping products (NVPs).
In the RACGP submission, the college is calling for:
- stronger border controls, including scrapping the personal importation scheme for NVPs and mandating that non-nicotine vaping products list ingredients, with fines for incorrectly labelled products
- stricter regulation of products, including an Australian Register of Therapeutic Goods-registered NVP to bring vaping products into line with other medicines
- cracking down on flavours and packaging, including pharmaceutical-like packaging with warnings about risks such as poisoning and burns; and
- restricting NVP supply to three months per prescription.
Both the RACGP and the AMA back the TGA’s proposal to establish a regulated source of quality NVPs by requiring registration in the ARTG, following successful evaluation of quality, safety, and efficacy for smoking cessation.
“The RACGP supports progressing toward an Australian Register of Therapeutic Goods (ARTG) registered NVP,” the college said in its submission. “This would give clinicians greater confidence about efficacy, quality and safety and bring NVPs into line with most medicines prescribed by doctors.”
However, the RACGP also noted that registration would likely push up the price of the products: “The cost of an ARTG-registered NVP and whether it may be subsidised for smoking cessation will need to be addressed. It would be necessary to educate consumers and health professionals as to the benefits of using a registered product, particularly as cost may be a barrier to its uptake.”
The college was concerned about an alternative proposal for the TGA to pre-assess NVPs against a quality and safety standard.
“The RACGP recommends specifying the quality and safety standard being used for the pre-market assessment to allow clinicians to make a fully informed decision on whether they wish to prescribe the product,” it said.
“From a practical prescribing perspective, it is understood that dosage of nicotine received through a NVP can vary greatly depending on the how the person inhales. For example, if the clinician is prescribing a lower dose of nicotine in the NVP, and the patient inhales more in order to receive a stronger dose, will this practice increase their exposure to the toxicants?
“This is an important question for prescribers and there is concern that the safety standards may not adequately address these types of clinical questions.”
The AMA also supports the registration proposal but noted its introduction would not be straightforward.
“There are challenges with this approach as there are currently no NVPs registered on the ARTG and vaping manufacturers have resisted registration of their products globally, the association said in its submission, adding that Australia should choose to be “a world leader” in the area.
“We expect that this change would lead to strong rejection by the industry and as such may create an environment where there are no NVPs registered on the ARTG leaving some people unable to lawfully obtain NVPs. This could lead them to pursue black market options or return to tobacco.
“As such, there will need to be interim measures put in place or a significant lead time.
“The TGA will need to take care in finding the balance between ensuring doctors and patients understand and are aware of the regulatory change and what it means for them, while not misleading patients into thinking that NVPs are TGA-approved.”
According to the AMA, patients might think NVPs were being assessed using the same methods and standards as other products registered on the ARTG.
