Ensuring Compliance: TGO 110 Guidelines and Dispensing Practices

The standards set out in TGO 110 play a pivotal role in upholding the quality and safety of nicotine vaping products within Australia. These regulations are designed to ensure that these products meet strict criteria for ingredients, concentrations, labelling, and packaging.

TGO 110: Standard for Nicotine Vaping Products: Australian Sponsors’ Duties

Australian sponsors, including pharmacists, play a crucial role in ensuring that imported unapproved nicotine vaping products meet TGO 110 labelling and packaging requirements. If these requirements aren’t met, it becomes the responsibility of the Australian sponsor to re-package or re-label the product.

Pharmacists as Sponsors

Pharmacists are considered sponsors when nicotine vaping products are imported directly, exported, or extemporaneously compounded. This designation comes with the duty to adhere to TGO 110 standards and guidelines.

Ensuring Safe Dispensing Practices

Dispensing nicotine vaping products requires strict adherence to safety and quality standards. Pharmacists must:

• Verify prescriptions for accuracy and completeness.
• Confirm the patient’s understanding of proper usage.
• Ensure that nicotine concentrations match the prescription.
• Check the product’s labeling for compliance with TGO 110.

Patient Education and Counselling

Education is paramount in helping patients make informed decisions. Pharmacists should:

• Provide detailed information on vaping devices, including proper usage and maintenance.
• Explain the importance of adhering to prescribed doses.
• Discuss common side effects and how to manage them.
• Offer guidance on recognizing signs of nicotine overdose.
• Highlight the necessity of storing products safely out of reach of children.

Advertising Guidelines: Ensuring Compliance in Pharmacies

Advertising prescription medicines to the public is generally prohibited in Australia. However, pharmacies can advertise the availability of nicotine vaping products dispensed upon prescription.

Advertising Prescription Medicines

Advertising of prescription medicines to the general public is strictly regulated in Australia. However, pharmacies that stock nicotine vaping products for prescription dispensing can advertise within certain parameters:

• The advertising exemption allows pharmacies to inform patients that these products are available in their pharmacy.
• The primary purpose is to ensure patients with prescriptions are aware of where to have them filled.
• It is essential to adhere to specific guidelines and restrictions outlined by regulatory authorities.

Ensuring Compliance and Responsibility

Pharmacies must exercise responsibility and strict compliance when advertising nicotine vaping products. This includes:

• Ensuring that any advertising content does not target the general public or encourage non-prescribed use.
• Adhering to guidelines and restrictions regarding the content and manner of advertising.
• Clearly communicating that these products are available by prescription only.
• Avoiding any promotion that may appeal to non-smokers or adolescents.

Pharmacist’s Role in Dispensing

Pharmacists must adhere to professional practice standards and guidelines when dispensing nicotine vaping products. We’ll emphasize the importance of compliance and safe practices.

Importing and Quality Assurance

To ensure product safety, pharmacists should confirm that imported nicotine vaping products meet TGO 110 standards.

Safety Considerations

Patients using nicotine vaping products face potential risks, including long-term health effects, poisoning, and dual-use with smoking. We’ll delve into these safety concerns.

Public Health Risks: Gateway Effect and Non-Smokers

Nicotine vaping products pose a significant public health risk by potentially acting as a gateway to tobacco use, particularly among non-smokers and adolescents:

• Research suggests that non-smokers who experiment with vaping may become more likely to try conventional tobacco products.
• This raises concerns about nicotine addiction and long-term tobacco use initiation, contributing to future public health challenges.
• Public health campaigns and restrictions aim to mitigate this risk by discouraging non-smokers and youth from using vaping products.

Intentional and Accidental Poisoning

Another public health concern associated with nicotine vaping products is the risk of poisoning:

• Intentional poisoning can occur when individuals, especially children, ingest or misuse vaping liquids.
• Accidental poisoning may result from improper storage, handling, or accidental exposure to nicotine-containing liquids.
• Raising awareness about proper storage, child-resistant packaging, and poison prevention measures is crucial to reducing these risks.

Nicotine Vaping Product Ingredients

Nicotine vaping products contain various components, including nicotine, carrier fluids, and flavourings.

Nicotine Formulations and Inhalation

Nicotine vaping products are designed to deliver nicotine to users through inhalation. Two primary nicotine formulations are used:

• Base Nicotine: This form of nicotine can cause adverse effects, such as throat irritation, at relatively low concentrations (typically above 20 mg/mL). For this reason, higher concentrations are often diluted before use.
• Nicotine Salts: Nicotine salts are created by combining base nicotine with an acid. They serve two crucial purposes:
• Reduced Irritation: Nicotine salts lower the pH of nicotine, reducing throat irritation.
• Lower Vaporization Temperature: Nicotine salts allow nicotine to vaporize at lower temperatures, making them more suitable for vaping devices.