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.
Changes to the scheduling of nicotine as a prescription-only medicine will mean liquid nicotine, commonly used in vaping, can only be legally supplied domestically by a pharmacist upon presentation of a prescription and evidence of a Therapeutic Goods Administration (TGA) approval (under the Special Access Scheme B or Authorised Prescriber Scheme).
In preparation, PSA is developing guidelines to support pharmacists in procuring and dispensing unregistered nicotine vaping products on prescription for people for whom they have been prescribed.
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 in accordance with 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.”
“While evidence is still emerging to support the use of vaporised nicotine in smoking cessation or harm minimisation, these changes are coming and pharmacists will be there to support patients who present with prescriptions.”
“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.”
PSA acknowledges the TGA’s work to date in establishing standards and draft guidance to help clarify the safety and quality requirements for such products.
“Regulators around the world are rightly cautious on the risks and benefits of inhaled nicotine delivered via electronic cigarettes. Vaping is largely unregulated and overseas its uptake has been largely driven by the tobacco industry.” A/Prof Freeman said.
“The TGA has taken appropriate steps to reduce the risk of harm to people currently using vaping products, but a fundamental problem remains – we don’t know how dangerous or how useful they will be in the long-term.”
“Pharmacists will need to do what they are trained to do, putting their patient’s health first and helping those willing to quit do so in the safest and most effective way possible.”