There has been an increase in medicinal cannabis (MC) prescribing and an expansion of pharmacist’s responsibility to ensure its safe and effective use. Based on incident reports and professional practice enquiries from the past year, PDL has identified several key areas of risk associated with the dispensing and supply of cannabis-based therapies and would like to highlight strategies for mitigation.
Potential risks
Dispensing
Below are examples of MC dispensing incidents that PDL are aware of.
- Wrong drug or strength: Instances where patients received the incorrect cannabis product or incorrect strength, dose or instructions.
- Wrong person: Occasions where MC was dispensed to the wrong person or dispensed to a person under false pretence. Additionally, instances where the product was delivered to the wrong address, increasing the risk of theft.
- Incorrect or excessive quantity: Reports of excessive quantities being supplied that are difficult to justify therapeutically, or incorrect quantities supplied such as 10 units instead of 10 grams. PDL has observed pharmacists dispensing prescriptions that have been ordered as a range in strength, such as cannabis flower 20-25% THC, which is not permitted. Pharmacists may be aware of the limited number of evidence based clinical guidelines to support decision making. When in doubt, it is important to consult with the prescriber and refer to current resources for guidance.
- Legislative non-compliance: Supplying MC with prescriptions that do not meet the legal requirements. Pharmacists must attach Cautionary Advisory Label 1 and have a conversation with the patient around driving safety. If the patient is not physically present, alternative methods for effective counselling should be explored.
Substitution
PDL has observed substitution practices that fall short of legislative standards, often compounded by stock shortages and challenges in contacting prescribers. Clear guidance is available from the various State and Territory Departments of Health that specify when substitution is appropriate, which pharmacists must adhere to. Pharmacists should be mindful of the nuances between the various states and territories.
Storage
Schedule 8 MC must be securely stored in the pharmacy’s controlled medicines safe. Failure to do so is often attributed to space constraints or oversight where MC products have been left out for collection. PDL is aware that regulators have concerns about storage lapses.
Documentation
Good documentation is important, however PDL is aware of MC prescriptions being dispensed and supplied:
- without accompanying Therapeutic Goods Administration (TGA) paperwork;
- with forged TGA documentation; and
- with a lack of contemporaneous note-taking.
Service and attitude
PDL has observed instances where the declinature to supply MC has led to frustration and aggression. Reasons to decline supply could include excessive use, incorrect TGA documentation, concerns of potential drug interactions, contraindications due to certain mental health conditions, differences in opinion between practitioners with regards to dosing or indication, just to name a few. Stock shortages and short-dated stock are other contributing factors that may lead to patient dissatisfaction.
Delivery, destruction and advertising
PDL have observed issues such as lost deliveries or misdirected shipments which highlight the importance of proper delivery protocol. We have also observed destruction
and advertising practices that do not comply with legislative requirements.
Real Time Prescription Monitoring (RTPM)
PDL have observed lapses with utilisation of RTPM, our recommendation is to check if RTPM is mandatory in your state or territory. PDL considers checking RTPM as best practice where utilisation is optional. Consideration around concurrent Opioid Replacement Therapy (ORT) use and the possible omission of ORT data from RTPM depending on the practice setting.
Lack of consideration when implementing a new service
PDL are aware of pharmacists, who have been approached by companies to engage in vertically integrated or telehealth models of MC provision. Vertically integrated models are not prohibited, however they are an area of focus for regulators. Pharmacists should carefully consider several factors, such as staffing requirements, the development of robust standard operating procedures, training and operational requirements to provide high quality care.
Challenges to engage directly with both patients and doctors have been reported. This may hinder the pharmacist’s ability to obtain a comprehensive medical history of the patient, including medication list and medical conditions. This can make it difficult to identify any interactions or contraindications. Additionally, pharmacists should factor in the need for a larger safe, and lead time required to order and install one. Security of data and retention of records should also be considered.
With these issues and challenges in mind, PDL would like to put forward the following risk mitigation strategies.
Risk mitigation strategies
Scope of practice
Pharmacists should appreciate the four elements that underpin one’s scope of practice, which are education, competence, authority by the legislation and accountability.
- Education
Consideration when accepting a position in a pharmacy specialising in MC without prior experience nor adequate opportunity for upskilling and training. - Competency
Engaging in continuing professional development (CPD) to enhance your skills in this area. - Authority
Familiarise yourself with legislative requirements around storage, substitution and documentation requirements. - Accountability
Remember that you are accountable for all your actions as a pharmacist.
Effective communication
Assessing whether to decline a supply requires clear communication with patients. Document your rationale thoroughly. Implement systems to monitor order statuses and provide timely updates, ensuring they align with patient expectations.
Robust documentation processes
Ensure that all MC supplied has the necessary TGA documentation. Maintain a clear timeline for recording S8 supplies in the Drug Register, and ensure all staff are aware of their reporting obligations.
Clinical acumen
When a patient presents with multiple prescriptions for MC, consider the overall safety and appropriateness. Ask yourself whether fulfilling a prescription simply because it is legal is in the patient’s best interest, taking into account their overall treatment plan and potential risks. PDL is aware of hospital admissions that have occurred due to drug interactions or contraindications. MC has a high potential for diversion. PDL would like to stress the importance of assessing each individual prescription critically, taking into consideration the patient’s history and all other relevant factors.
Governance and Standard Operating Procedures
The reporting of incidents is important to help identify risks and address gaps in practice. Pharmacies should establish clear policies for situations where a prescriber cannot be contacted and ensure that delivery protocols are clear. For instance, ensuring that packages are tracked and signed for upon receipt.
Fostering a culture of safety and openness in incident reporting is essential. Promote continuous quality improvement (CQI) by reflecting on contributing factors and developing prevention strategies.
As the landscape of MC evolves, pharmacists play a crucial role in safeguarding patient health. By identifying potential risks and implementing effective mitigation strategies, we can enhance the safe and responsible use of MC in our communities.
This proactive approach will not only protect patients but also uphold the integrity of our profession in the ever-changing healthcare environment.
Additional resources
- NSW Medicinal Cannabis Guidance
- PDL Scope of Practice CHECKLIST
- PDL CPD activity – Dealing with agression in pharmacy
- PDL CPD activity – Look before you leap! A risk management guide to introducing a new pharmacy service
PDL members can call 1300 854 838 for advice and incident support from one of our Professional Officers.
