Guidelines for Dispensing Medicinal Cannabis
As seasoned professionals in the pharmaceutical field, you're well aware of the ever-evolving landscape of healthcare, particularly concerning emerging therapies like medicinal cannabis.
In Australia, the dispensing of medicinal cannabis is subject to stringent regulations and guidelines outlined by regulatory bodies such as the Therapeutic Goods Administration (TGA).
In this guide, we'll explore the nuances of dispensing medicinal cannabis and provide you with relevant government links to navigate this complex terrain effectively.
Understanding the Regulatory Framework
The regulation of medicinal cannabis in Australia is governed by the Therapeutic Goods Act 1989 and its associated regulations, including the Narcotic Drugs Act 1967 and the Poisons Standard.
These regulations classify medicinal cannabis as a Schedule 8 (controlled) substance, imposing strict requirements on its prescribing, dispensing, and use. As pharmacists, it's imperative to familiarise yourselves with these regulations to ensure compliance and mitigate potential risks.
Under Australian law, medicinal cannabis products can only be obtained with a valid prescription from an authorised healthcare practitioner.
The prescription must comply with specific requirements outlined by the TGA, including the prescriber's qualifications, patient information, dosage instructions, and product details.
You play a critical role in verifying the authenticity and legality of prescriptions, ensuring that they meet all regulatory criteria before dispensing medicinal cannabis products to patients.
Dispensing Medicinal Cannabis
When dispensing medicinal cannabis products, pharmacists must consider various factors, including product formulation, potency, dosage form, and patient-specific requirements.
A pharmacist can dispense a Schedule 8 cannabis medicine only on receipt of a handwritten or electronic prescription, when dispensing from a handwritten Schedule 8 prescription you must conform to the legal requirements in every respect, the pharmacist must verify the prescriber, must report any apparently forged or fraudulently altered prescriptions, and must retain the dispensed prescription, separately from other prescriptions.
When dispensing from an electronic prescription, the patient's date of birth must be recorded in the dispensing system. Cannabis medicines supplied to a patient by a clinic or authorised prescriber must be labelled with a dispensing label with the usual details required for any dispensed medicine.
It's essential to maintain a comprehensive inventory of medicinal cannabis products to cater to diverse patient needs while ensuring quality, safety, and efficacy.
Patient Education & Counselling
As pharmacists, you possess the expertise to provide comprehensive patient education and counselling on the safe and appropriate use of medicinal cannabis.
This includes discussing dosage regimens, administration methods, potential side effects, drug interactions, and legal considerations with patients.
By empowering patients with accurate and evidence-based information, advanced pharmacists play a vital role in optimising therapeutic outcomes and promoting patient adherence and safety.
Documentation and Record-Keeping
Comprehensive documentation and record-keeping are essential aspects of medicinal cannabis dispensing, as mandated by regulatory authorities.
Pharmacists must maintain accurate records of all dispensed prescriptions, including patient demographics, prescriber information, product specifics, dispensing dates, and quantities supplied.
These records not only ensure compliance with regulatory requirements but also facilitate accountability and traceability in the event of audits or inquiries.
All supplies and receipts of Schedule 8 cannabis medicines (whether dispensed on prescription or supplied directly by an authorised prescriber) must be recorded in a drug register. If used in a clinical trial, a record of the NSW Authority number must be made in the clinical trial records.
Medicinal Cannabis Storage
➲ 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:
➲ The refrigerator must be in a room (which includes a part of a room or an enclosure) to which the public does not have access.
➲ The refrigerator, or any cupboard or receptacle in which the refrigerator is kept, must be securely attached to a part of the premises.
➲ The refrigerator, or the room, cupboard or receptacle in which the refrigerator is kept, must be kept securely locked when not in immediate use.
➲ A device (including a key) that is used to securely lock anything under this subclause must:
- be kept on the person of a pharmacist who is at the premises, or be securely locked in a safe that can be unlocked only by a pharmacist.
- a code or combination that is used to securely lock anything under this subclause must not be disclosed to any person who is not a pharmacist.
➲ The refrigerator must not be used to store any other item that is not a substance listed in Schedule 2, 3, 4 or 8 of the Poisons List or is not a therapeutic good.
Summary
In dispensing a medicine, pharmacists must comply with all legislation relevant to the practice of pharmacy in the jurisdiction where the practice occurs ensure that dispensing is done in accordance with the prescriber's intentions not dispense a prescription without satisfying themselves that it is safe, appropriate and lawful to supply the medicine.