Managing Schedule 8 Medicines Safely
Published: 13 January 2021
Published: 13 January 2021
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 Regulations 2017).
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).
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:
(Poisons Standard October 2020)
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).
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:
As a result of this research, there have been many changes implemented by TGA, including:
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).
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).
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).
When administering a Schedule 8 medicine, you must refer to either:
(VIC DoH 2015b)
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:
(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).
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:
(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.
Ausmed’s Editorial team is committed to providing high-quality and thoroughly researched content to our readers, free of any commercial bias or conflict of interest. All articles are developed in consultation with healthcare professionals and peer reviewed where necessary, undergoing a yearly review to ensure all healthcare information is kept up to date. See Educator Profile
Jenny is a practicing pharmacist, a Teaching Associate at Monash University and Clinical Associate at RMIT university . She is a current member of the PSA Branch committee, Editorial Board Member of AUS-DI (Drug information), Guidelines Committee for the National Asthma Council Australian Asthma Handbook, and RACGP Silver book for Aged Care . Jenny is an accredited consultant pharmacist, and conducts her own company focussing on medication reviews in the home and Aged Care Facilities as well as Quality Use of Medicine consultancy. She works regularly in community pharmacy plus sessions in a GP clinic at a Community Health Centre. Jenny has published over 380 educational articles and presents hundreds of talks annually. In 2010 Jenny received the Sanofi-Aventis award by the University of Sydney, in 2013, PSA Australian Pharmacist of the Year and 2016 Jenny was the AACP-MIMs Consultant Pharmacist of the Year. See Educator Profile