Storage of Medical Cannabis in Australian Pharmacies
6 minute read. 📙 Pharmacists
Storage of medical cannabis in pharmacies comes with its own set of legalities and regulations that must be adhered to.
In this comprehensive guide, we will delve into the legal requirements surrounding the storage of medical cannabis in Australian pharmacies, ensuring compliance and patient safety.
Understanding the Legal Framework
Australia has a complex legal framework governing the cultivation, production, prescribing, and dispensing of medical cannabis. The key legislation and regulations that pharmacies need to be aware of include:
Therapeutic Goods Act 1989: This legislation regulates the supply, import, export, manufacturing, and advertising of therapeutic goods, including medical cannabis products.
Narcotic Drugs Act 1967: Under this act, licenses are required for the cultivation, production, manufacture, and supply of cannabis for medicinal purposes.
Poisons Standard: The Poisons Standard, also known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), categorises substances into schedules based on their potential for harm and therapeutic use. Cannabis and cannabis products are included in Schedule 8, requiring special precautions for storage and dispensing.
Medicinal Cannabis Medical Schedules
Medications and substances are categorised into different schedules based on their potential for harm and therapeutic use. Two of these schedules, Schedule 8 and Schedule 4, are particularly relevant to medical cannabis.
Products containing 98% or more cannabidiol (CBD), and in which any other naturally occurring cannabinoids other than CBD eg, tetrahydrocannabinol (THC) comprise 2% or less of the total cannabinoid content, are Schedule 4 prescriptions. In general, products that contain THC are classified as Schedule 8.
Schedule 4 (S4)
Schedule 4 substances are prescription-only medications that are considered to have a moderate risk of harm if misused. These medications are available only with a prescription from an authorised healthcare professional, such as a doctor or dentist.
Examples of Schedule 4 substances include many common medications, such as antibiotics, antidepressants, and blood pressure medications.
While Schedule 4 medications are subject to regulations governing their prescribing and dispensing, they are generally considered to have a lower potential for abuse and dependence compared to Schedule 8 substances.
Pharmacists play a key role in ensuring the safe and appropriate dispensing of Schedule 4 medications, including counselling patients on their proper use and potential side effects.
Schedule 8 (S8)
Schedule 8 substances are classified as controlled drugs, which have a high potential for abuse and dependence. These substances are subject to stringent regulations regarding their prescribing, dispensing, storage, and handling.
Examples of Schedule 8 substances include opioids (e.g., morphine, oxycodone), benzodiazepines (e.g., diazepam, alprazolam), and cannabinoids (e.g., medical cannabis).
Medical cannabis falls under Schedule 8 due to its psychoactive properties and potential for misuse.
Dispensing of Schedule 8 medications typically requires a prescription from a medical practitioner, and pharmacists must adhere to strict record-keeping and reporting requirements.
Storage Requirements
Compliance with storage requirements is essential to ensure the safety, efficacy, and integrity of medical cannabis products. The following considerations should be taken into account.
Security
Medical cannabis must be stored securely to prevent unauthorised access or theft. Pharmacies should have robust security measures in place, such as alarms, surveillance cameras, and restricted access to storage areas.
Temperature Control
Proper temperature control is crucial to prevent degradation of medical cannabis products. Storage areas should maintain temperatures within the range specified by manufacturers and regulatory guidelines.
Light Protection
Exposure to light can degrade the potency and quality of medical cannabis. Pharmacies should store cannabis products in opaque containers or cabinets to minimise exposure to light.
Humidity Control
Excessive humidity can promote the growth of mould and mildew, compromising the quality of medical cannabis. Storage areas should be kept dry, and humidity levels should be monitored and controlled as per regulatory requirements.
Child-Resistant Packaging
Medical cannabis products must be stored in child-resistant packaging to prevent accidental ingestion by children. Pharmacies should ensure that packaging complies with relevant safety standards.
Storage of Schedule 8 Medicines
➲ Schedule 8 cannabis medicines must be stored separately and securely, as is required for any Schedule 8 medicine.
➲ In a retail pharmacy or hospital pharmacy, a Schedule 8 medicine that requires refrigeration may be kept in a refrigerator rather than a safe if all of the following requirements are met:
Documentation and Record-Keeping
Accurate documentation and record-keeping are essential for demonstrating compliance with regulatory requirements. Pharmacies should maintain records related to the receipt, storage, dispensing, and disposal of medical cannabis products.
Purchase Records
Records of medical cannabis purchases, including supplier information, product details, quantities, and dates of receipt.
Dispensing Records
Documentation of medical cannabis dispensed to patients, including patient details, prescriber information, product details, quantities dispensed, and dates.
Inventory Management
Regular inventory checks should be conducted to reconcile stock levels and identify any discrepancies or losses.
Security Logs
Logs documenting access to medical cannabis storage areas, including details of personnel authorised to access the storage area and the purpose of access.
Summary
Ensuring compliance with legal requirements for the storage of medical cannabis in Australian pharmacies is essential to protect patient safety, maintain product integrity, and mitigate regulatory risks.
By understanding and adhering to the relevant legislation and regulations, pharmacies can play a vital role in providing access to medical cannabis therapy for patients in need while upholding the highest standards of professionalism and integrity.