Greetings to all my new friends and loyal readers! As early as the previous year we already faced a ban on Vape emails, and also received the related notification about Therapeutic Goods Administration (TGA) announced a decision on 21 December 2020 that from 1 October 2021, the importation of Nicotine e-cigarettes and also liquid Nicotine (e-juice) for vaping will call for a valid prescription. Therefore, the Pharmaceutical Society of Australia (PSA) is urging all pharmacists to be aware of regulatory changes to Nicotine vaping, which come into effect on 1 October 2021.
What PSA Urges All Pharmacists To Do?
According to a policy document released by the PSA, vaping products that contain Nicotine will only be available in Australia through a prescription from a doctor, through a pharmacist, with heightened scrutiny from the Therapeutic Goods Administration (TGA).
PSA National President, A/Prof Chris Freeman, encourages pharmacists to prepare to manage these changes and support more than 200,000 Australians estimated to be using vaporised Nicotine.
Liquid Nicotine is not currently available through the pharmaceutical supply chain. As an unapproved product, pharmacists will need to have clear processes in place to ensure liquid Nicotine supplied on prescription and under the TGA’s approval, complies with the TGA’s product standard for unapproved vaping products, Therapeutic Goods Order 110. The standard includes requirements related to labelling (e.g. warnings and Nicotine content), packaging (child-resistant closures), ingredients and contaminants.
What Is Happening To The Law Regulating Of Nicotine Vaping?
Nicotine is already a Schedule 4 Prescription Only Medicine in the Poisons Standard when in preparations for human therapeutic use. The changes clarify the scheduling of Nicotine and close a regulatory gap between Commonwealth and state and territory laws.
Under existing state and territory laws, the sale of Nicotine e-cigarettes and liquid Nicotine without a prescription is illegal throughout Australia. Additionally, the possession or use of these products without a prescription is illegal in all states and territories except South Australia. The decision means that importing Nicotine e-cigarette products from overseas websites without a valid doctor’s prescription will be illegal.
Nicotine e-cigarettes will require a prescription
Consumers will need a valid Australian prescription (script) to access Nicotine e-cigarettes and liquid Nicotine. This will provide an opportunity for consumers to receive appropriate medical advice on options for smoking cessation.
Obtaining Nicotine e-cigarettes
There are currently no TGA approved Nicotine e-cigarettes in the Australian Register of Therapeutic Goods (ARTG). Medicines not included in the ARTG are known as ‘unapproved’ medicines. There are established pathways for legal access to unapproved Nicotine e-cigarettes, with a valid prescription.
Personal importation
Consumers can import Nicotine e-cigarettes legally through the TGA Personal Importation Scheme, with a doctor’s prescription. Any medical practitioner who considers it is appropriate for their patient to use Nicotine e-cigarettes for smoking cessation can prescribe Nicotine e-cigarettes for personal importation. Medical practitioners do not need TGA approval to prescribe Nicotine e-cigarettes for their patients when they access them through the personal importation scheme.
Supply in Australia
Consumers will also be able to obtain Nicotine e-cigarettes from local pharmacies and Australian based online pharmacies, with a prescription from an Authorised Prescriber. Medical practitioners would need to apply to the TGA for authority to prescribe unapproved Nicotine e-cigarettes as an aid to stop smoking through the simplified Authorised Prescriber Scheme or the Special Access Scheme (SAS). Depending on state or territory restrictions, other prescribing health practitioners may also be able to apply under the SAS.
A simplified Nicotine-specific online form is available on the Authorised Prescriber dashboard of the SAS & Authorised Prescriber Online System. Once approved, the authorisation is valid for five years and the Authorised Prescriber may, following the RACGP guidelines to support smoking cessation, prescribe Nicotine for smoking cessation to patients without any further required TGA approval.
How Do The Pharmacists Deal With The Changes?
PSA Victorian President Benjamin Marchant said pharmacists were the most frequently contacted health professionals in Victoria, yet their skills were not being put to full use. A recent survey conducted in Brisbane found that more than one-third of pharmacy staff (39%) had been asked about “e-cigarettes” by their customers.
Pharmacists play a key role in providing harm reduction interventions, but not all pharmacists are confident in guiding the use of Nicotine vaping products (NVPs), the researchers said. Therefore, a large number of pharmacists will need some knowledge training on this policy change.
Given the significance of changes to the regulation of Nicotine and the high number of people currently using vaporised Nicotine, it is essential that pharmacists are guided with appropriate resources including clinical guidelines and practice support tools to assist their patients.
What Vapers Should Do With The Vaping Changes?
Until after that, it had been an obstacle for several to locate a doctor that recognized the advantages of e-cigarettes and was prepared to prescribe pure Nicotine. Fortunately, in January 2020, the Royal Australian University of General Practitioners (RACGP) officially transformed its position on e-cigarettes. Previously opposed to e-cigarettes, Nicotine-based e-cigarettes are now advised as an aid ideal for smokers looking to give up.
Therapeutic Goods Administration director, Adjunct Professor John Skerritt, was grilled at length by members of the Senate Community Affairs Committee at an Estimates hearing held on 1 June. In response to questions from Senator Holly Hughes (Lib, NSW), about online pharmacies and compounders selling e-cigarettes with premixed Nicotine liquids, Dr Skerritt said: “there will be three models whereby people will get Nicotine on a doctor’s prescription.
They can import products directly themselves from overseas, and that’s what the 110,000 doctors can write a script for now, or, as an authorised prescriber—and, again, in discussion with RACGP, we are not promoting that pathway, and neither are they, and they’re the GPs, not us.
“We want to make this a simple as possible, so we have been working with pharmacy groups so that as many suburban community pharmacists will stock Nicotine products that can be dispensed on receipt of a prescription”.
Ultimately, with the new vaping regulations, Nicotine prescriptions have become indispensable to prove the purchase of Nicotine products. If you need a Nicotine prescription or would like to know more, you are welcome to visit our VapePenZone online store, where we have relevant doctors to provide you with professional advice!
Also, if you need to know more about Nicotine prescriptions, please see here for details.
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