A dental scenario: A dental assistant, at the dentist’s direction, supplied an anxious patient with Serepax (oxazepam) prior to surgical extraction of a tooth.
An entry was made in the electronic records that Serapax had been given including details of date and time the medication was provided. However, the dental assistant who entered the notes did not record which dental practitioner had actually prescribed the medication. Furthermore, there was nothing in the notes regarding any medical history including questions regarding any other medication for screening of potential drug interactions.
The patient experienced a dry socket and subsequently complained. The regulatory authority investigated the complaint.
Many dental practices store medication that is classed as scheduled medication onsite including for pain relief post treatment and for sedative purposes prior to treatment and for anxious patients.
Each state and territory within Australia has its own specific drugs, poisons and controlled substances legislation and regulations. Practitioners should ensure that they are familiar with the applicable rules and regulations that apply in the state or territory in which they operate.
Though each state’s legislation is different, all states and territories in Australia have in place legislation, regulations and codes of conduct which impose significant restrictions and responsibilities about obtaining, storing, supplying, destruction and recording of information in connection with controlled drugs (often referred to as Schedule 8 drugs of dependence) and restricted drugs (often referred to as Schedule 4 or prescription only medications). Furthermore, a number of Schedule 4 medications are classed as potential drugs of dependence; this includes benzodiazepines, which includes oxazepam.
What should you do next?
The message to practitioners and especially practice owners and practice principals is as follows:
Conduct an audit of all medication stored at the practice. Put in place systems/protocols to ensure up-to-date accountability and auditability of all medications that are stored on site.
Know the classification (i.e. scheduling) of all medications stored at the practice pursuant to the relevant legislation/regulation in your state or territory.
Be aware of any specific requirements for obtaining, storing, supplying, recording of information and destroying of medications based on their classification. For example, Schedule 8 medications must be locked securely in a safe or compartment which is fastened to the building infrastructure and kept locked at all times and with restricted access. In some states, a permit is required to store or prescribe certain Schedule 8 medications.
Many scheduled medications require the maintenance of a specific drug register. Do the medications stored and supplied to patients at your practice require the maintenance of such a register?
Be mindful that drug classifications can change from time to time. For example, alprazolam (Xanax) became a Schedule 8 controlled substance in 2014. It was previously a Schedule 4 medication.
For dental practitioners who write prescriptions or directly supply onsite scheduled medications to patients at the practice:
be familiar with rules regarding the requirement for there to be a therapeutic indication for the prescription/supply of any medication to a patient;
be aware that some controlled substances require a permit or specific authorisation for possession, supply or prescription;
crucially, maintain detailed and accurate records regarding the prescription or supply of medication including obtaining a relevant history prior to prescription or supply. These requirements are set out in applicable State legislation and regulations, are a core part of good dental practice, and align with dental record keeping requirements under the Dental Board of Australia’s Guidelines on Dental Records.
Dentists should also be aware that breaches of state-based drugs, poisons and controlled substances legislation and associated regulations may constitute statutory offences, which can carry significant criminal and civil penalties, and the risk of a criminal conviction if prosecuted.
The same circumstances can also lead to disciplinary action by the Dental Board of Australia, which can affect the practitioner’s registration.
The statutory departments that administer the drugs and poisons legislation can and do refer matters to AHPRA to investigate. And similarly, AHPRA can and does refer matters to the relevant statutory health departments to prosecute breaches of legislation where relevant.
Please contact our Health Law team if you have any questions.