Schedule 8 medicines are associated with significant risks. It is essential to be aware of your professional obligations when managing and administering these medicines for your clients.
This article is intended for registered nurses and medication endorsed enrolled nurses, although the principles apply to all staff who manage and/or administer medication, including personal care assistants/other care workers working under supervision.
Note: This article primarily references Victorian legislation, however, you can find resources about other state legislation at the end of this article.
Scheduling is the classification system used in Australia to regulate the availability of medicines and poisons. Medicines and poisons are classified into one of 10 schedules depending on the level of safety risk they pose. Each schedule has its own level of regulatory control that dictates how freely available it is to the general public, with lower-risk medicines generally being less tightly regulated (TGA 2019; Drugs, Poisons and Controlled Substances
The aim of scheduling is to protect the health and safety of the general public by exercising greater control over medicines that are more likely to cause harm or be misused (Healthdirect 2020).
What are Schedule 8 Medicines?
Schedule 8 medicines are ‘controlled drugs’ that must meet specific conditions when being produced, supplied, distributed, owned and used (Drugs, Poisons and Controlled Substances Regulations 2017).
Like Schedule 4 medicines, Schedule 8 medicines are prescription-only. However, they are more tightly controlled than those in Schedule 4.
Schedule 8 medicines are classified as drugs of dependence. While they offer significant therapeutic benefits including severe pain relief (for cancer and major surgery) and management of attention-deficit/hyperactivity disorder (ADHD), they also pose a high risk of misuse, abuse and dependence. For this reason, they require strict regulation (Drugs, Poisons and Controlled Substances Regulations 2017; Healthy WA 2020; PBS 2020).
Medicines that are classified as Schedule 8 include:
Opioid analgesics, including:
Oxycodone with naloxone;
Benzodiazepines (flunitrazepam and alprazolam); and
(Poisons Standard October 2020)
What are the Risks of Schedule 8 Medicines?
Schedule 8 medicines are associated with a risk of dependence, and consequently drug-seeking behaviour. This term describes a range of activities that may be performed in order to obtain a desired medicine for the purpose of misuse (James 2016).
Drug-seeking behaviour and medicine misuse may adversely affect relationships, finances and mental and physical health. It may also have legal consequences if the individual partakes in unlawful activities (DoH 2019).
Programs such as SafeScript in Victoria and Drugs and Poisons Information System Online Remote Access (DORA) in Tasmania and the ACT, plus other real-time monitoring programs in other states are being used to identify overuse, fraudulent behaviour and ‘doctor shopping’, which occurs when an individual attempts to illicitly obtain a medicine from multiple practitioners simultaneously (VIC DoH 2020c; Choahan 2018).
However, while real-time monitoring programs can help identify patients who are at-risk, they may also have unintended consequences. Practitioners may negatively stereotype at-risk patients, fear sanction or hold other concerns that lead to a patient receiving delayed treatment or being discharged from care entirely. Even the term ‘doctor shopping’ may be unhelpfully contributing to the stigmatisation of these people. Therefore, it is important that those patients identified 'at-risk' are treated with respect and receive individualised care free from bias (Dobbin & Liew 2020).
Issues Related to Opioids
Compared to illegal opioids (such as heroin), pharmaceutical opioids are responsible for significantly more deaths and poisoning hospitalisations in Australia. Every day, there are about 150 hospitalisations, 14 emergency department admissions and three deaths related to opioid use (TGA 2020).
According to research conducted by the Therapeutic Goods Administration:
Only half (53%) of those taking opioids knew they were taking an opioid medication, and 18% were unfamiliar with the term ‘opioids’;
Only 17% of those taking opioids believed they were using them safely and effectively and that they were not dependent;
Only 2% of those taking opioids could identify every prescription opioid medicine;
Only half (56%) of those taking opioids believed they were using them safely; and
One-third (30%) of those taking opioids considered themselves dependent.
As a result of this research, there have been many changes implemented by TGA, including:
Smaller pack sizes for immediate-release prescription opioids, reducing the circulation of unused opioids in the community;
Safety information, including relevant warnings, being prominently displayed in the Consumer Medicines Information (CMI). This aims to ensure that language and information remains consistent across all prescription opioid classes;
Indications in the PI documents for immediate release and modified release products reinforcing that opioids should only be used when other analgesics are not appropriate or have been proven ineffective.
Hydromorphone and fentanyl modified release products being contraindicated for ‘opioid naive patients’, i.e. those who do not already use opioids regularly;
Stronger restrictions for the use of fentanyl, which is one of the strongest opioids available in Australia; and
Increased education for both prescribers and consumers.
Prescribing Schedule 8 Medicines
Depending on the state or territory in which they are operating, the prescriber may need to obtain a permit in order to prescribe a Schedule 8 medicine. The exact requirements, including who can prescribe and how long they are allowed to prescribe for will depend on the jurisdiction and patient’s medical diagnosis. PBS regulations have also changed to reduce opioid prescribing.
A pharmacist can not supply a Schedule 8 medicine on a chart instruction given on a paper residential medication chart. Instead, a separate prescription for the Schedule 8 medicine is required (VIC DoH 2020d).
However, amendment regulations that came into effect on 23 July 2020 will allow authorised pharmacists to supply Schedule 8 medicines on an electronic National Residential Medication Chart (eNRMC) instruction. An electronic residential medication chart is defined as ‘a residential medication chart in an electronic form in accordance with the requirements of the Commonwealth Regulations’ (VIC DoH 2020d).
In the case of an emergency (as determined by the prescriber), a pharmacist can lawfully supply a resident’s Schedule 8 medicine upon verbal instruction from the prescriber (Drugs, Poisons and Controlled Substances Regulations 2017).
In such circumstances, the prescriber who issued the verbal instruction must provide written confirmation (most commonly in the form of a prescription) to the pharmacist as soon as practicable (Drugs, Poisons and Controlled Substances Regulations 2017).
In Victoria, permits are not required in order to prescribe Schedule 8 medicines to aged care residents or hospitalised patients, as they do not manage their medicines personally. This greatly decreases the risk of concurrent prescribing or doctor shopping (VIC DoH 2020b).
Possessing Schedule 8 Medicines
It is a criminal offence to possess a Schedule 8 medicine unless authorised. However, a registered nurse (or other appropriately qualified practitioner) is allowed to possess a Schedule 8 medicine for the purpose of administering it to a patient in their care. This must be done in accordance with other specific conditions (VIC DoH 2020a).
Supplying Schedule 8 Medicines
Only practitioners who have been endorsed by the Nursing and Midwifery Board of Australia are allowed to supply Schedule 8 medicines (i.e. provide a medicine to be administered at a later time). However, even if you are not endorsed, you are still allowed to deliver medicines (apart from starter packs) to clients as long as they have been lawfully supplied (VIC DoH 2020a).
Administering Schedule 8 Medicines
In Victorian residential aged care facilities, a registered nurse must manage Schedule 8 (and Schedule 4) medicine administration in adherence with relevant requirements from the Nursing and Midwifery Board of Australia. This nurse may choose to delegate medicine administration duties to other staff including other nurses, endorsed enrolled nurses and personal care workers, as long as they are appropriately qualified (VIC DoH 2015b).
When administering a Schedule 8 medicine, you must refer to either:
Written directions from a medical practitioner (or other authorised practitioner);
In the case of an emergency, oral instructions from a medical practitioner (or other authorised practitioner);
A written transcript of emergency instructions by the nurse who received them; or
Directions for use on the medicine’s container, which have been provided by a medical practitioner, pharmacist or other authorised practitioner.
(VIC DoH 2015b)
Storing Schedule 8 Medicines
There are specific guidelines for the storage of Schedule 8 medicines in residential aged care facilities.
In Victoria, Schedule 8 medicines must be stored in either:
A locked room; or
A locked storage facility that is fixed to a floor or wall.
(VIC DoH 2015b)
Steel medicine cabinets are strongly recommended for medicines that are being stored in their original containers or are unsuitable to be stored in dose administration containers. There are certain cases in which steel medicine cabinets are required (VIC DoH 2015b).
In some cases, unused components of a Schedule 8 medicine or its container may need to be destroyed or discarded. This must be recorded. A witness is required while the medicine is being destroyed (VIC DoH 2015b).
Identifying Drug-Seeking Behaviour
In addition to adhering to legislation and guidelines related to Schedule 8 medicines, it is also important to be aware of potential drug-seeking behaviour.
Look out for clients who:
Aggressively complain that they need a certain medicine, or ask for a specific medicine or dose by name;
Ask for their dose to be increased;
Claim that they are allergic to alternatives of the medicine they are requesting, or that they ‘don’t work’;
Become angry when questioned about their symptoms;
Are evasive, vague or unwilling to provide information when asked about their medication history;
Have a significant level of knowledge about medicines and symptoms;
Take extra or unauthorised doses;
Refuse to consider alternative medicines or options;
Appear more concerned about the medicine than the health issue they are taking it for;
Use threats or bribery to obtain medicine;
Are demanding or impatient;
Reduce social and other activities due to adverse drug effects.
(James 2016; The Avant Learning Centre 2016; SEMPHN 2019)
Note: Legislation and requirements may differ between states and territories. Always refer to your organisation's policy on Schedule 8 medicines.
State and Territory Resources for Schedule 8 Medicines