Prescribing therapeutic vapes: overview of the regulatory changes
TGA Australia・59 minutes read
Regulatory changes in Australia address the rise of vape use, especially among youth, with the federal government planning to ban all non-therapeutic vapes. Prescribing therapeutic vapes for smoking cessation requires adherence to TGA regulations, including authorized prescriber processes and state legislation.
Insights
- Australia is implementing strict regulations on vapes, requiring therapeutic vapes with nicotine to be obtained only through pharmacies or personal importation with a valid prescription, while non-therapeutic vapes pose risks, primarily to young people.
- Prescribing therapeutic vapes involves navigating authorized prescriber processes due to their unapproved status, requiring special access schemes or notification for approval, and dispensing them through registered pharmacists adhering to TGA requirements, with a focus on compliance with state and territory regulations.
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Summary
00:00
Australia Implements Regulations on Therapeutic Vapes
- The webinar aims to inform medical practitioners about prescribing therapeutic vapes for smoking cessation and nicotine dependence.
- Regulatory changes in Australia were prompted by the rise in vape use, especially among youth, leading to health risks.
- The federal government plans to ban all vapes in Australia unless they comply with therapeutic regulations.
- Therapeutic vapes with nicotine could only be obtained through pharmacies or personal importation with a valid prescription.
- Non-therapeutic vapes were sold by non-pharmacy retailers, creating risks for young people.
- The ban on vape sales will affect tobacconists, vape shops, and convenience stores.
- The timeline includes import restrictions on disposable vapes and further restrictions by March 2024.
- The Therapeutic Goods Act regulates therapeutic goods in Australia, ensuring quality, safety, and efficacy.
- Vapes may be recommended for patients who failed to quit smoking with other methods, following guidelines from the Royal Australian College of GPs.
- Prescribing therapeutic vapes requires special access schemes or authorized prescriber processes due to their unapproved status.
18:32
Regulations for Dispensing Therapeutic Vapes in Australia
- To provide a therapeutic Vape, including zero nicotine Vapes, approval under an authorized prescriber or notification is required.
- Vaping devices without substances can be supplied by registered pharmacists or authorized individuals under state or territory legislation.
- Pharmacists can dispense therapeutic Vapes conforming to TGA requirements from a published list of approved products.
- Transitional arrangements allow the sale of existing lawful nicotine Vape stock for smoking cessation purposes.
- Dispensing therapeutic Vapes requires evidence of authorized prescriber approval, SASB approval, or compliance with the SASP pathway.
- A new validation tool for pharmacists verifies notification reference numbers on prescriptions for dispensing therapeutic Vapes.
- Familiarizing oneself with available products in the area and prescribing products conforming to TGA requirements is crucial.
- State and territory regulations must be followed when prescribing therapeutic Vapes to ensure compliance.
- Therapeutic Vapes can be prescribed long-term, with guidelines recommending three-monthly reviews and a maximum of 12 months of use.
- Written consent from patients is necessary when prescribing unapproved therapeutic goods, and informing other healthcare providers is essential as per good clinical practice.
36:37
Challenges and Support for Vaping Cessation
- Vaping has rapidly increased, with some users surprised by its addictiveness and many reporting that their vaping habit surpassed their smoking habit soon after starting.
- Vapes are allowed in places where smoking is not, leading to continuous vaping without a clear end like a cigarette, posing challenges.
- Negative health effects from vaping range from mild discomfort to severe issues requiring medical attention, with some users feeling shame about their nicotine addiction.
- Some users reported benefits like mood regulation and feeling vaping was safer or cleaner than smoking.
- Difficulty in reducing or quitting vaping is common due to concerns about nicotine withdrawal and the perceived expense of nicotine replacement therapy compared to vaping.
- Quit Line services are viewed positively for providing support for nicotine addiction and quitting, but lack specific advice on vaping due to limited evidence.
- Providing care according to RACGP provisional guidelines involves offering brief advice, pharmacotherapy, and referrals for behavioral interventions for nicotine dependence, especially challenging in vapers.
- Quit Line is a confidential telephone counseling service tailored to various populations, including young people, pregnant individuals, and those with mental illness, offering multi-session behavioral support.
- Clinicians need to be alert to signs of vaping-related issues in young people, using comprehensive engagement approaches like the HEAD psychosocial review to provide support and link them to appropriate services.
- Behavioral interventions for smoking and vaping cessation involve intensive counseling over multiple sessions, tailored to individual needs, using established therapeutic approaches like cognitive behavioral therapy and motivational interviewing.
54:51
Support and Pharmacotherapy for Vaping Cessation
- Dr. Cole mentions the importance of online and peer group support for young people in vaping cessation.
- In the absence of evidence, it is suggested to cautiously apply what works for tobacco cessation to vaping cessation.
- Nicotine replacement therapy is recommended as a first-line pharmacotherapy for vaping cessation.
- Limited studies support the use of varenicline for vaping cessation.
- Bupropion's effectiveness for vaping cessation is uncertain due to lack of studies.
- Behavioral support is crucial alongside pharmacotherapy for vaping cessation.
- Some individuals, especially those under 18, may be highly dependent on nicotine from vaping, making approved pharmacotherapy less effective.
- Various risks associated with vaping include long-term health effects, poisoning, and nicotine exposure.
- Prescribing nicotine vaping devices requires consideration of device type, nicotine concentration, and individual usage habits.
- Initial starting doses for vaping pods and liquids vary based on dependency levels and may need adjustment after patient review.
01:12:42
TGA Evaluates Data Standards and Online Prescribing
- The TGA has received representations regarding data generation and trials, but the efficacy and safety standards may be too high for immediate success in evaluations.
- Online prescribing companies' regulation is under consideration by the TGA, drawing from experience with similar models in medicinal cannabis, with ongoing interest in the matter.
- Practitioners' conduct falls outside the Therapeutic Goods Act's scope, regulated by the Medical Board through ARA, emphasizing adherence to telehealth guidelines and readiness to take action against non-compliance.
