Managing Schedule 8 Medicines Safely

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Published: 12 February 2024

Schedule 8 medicines are associated with significant risks. It’s 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. However, 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. See: https://www.health.vic.gov.au/public-health/medicines-and-poisons-regulation

However, you can find resources about other state legislation at the end of this article.

Staff working in residential aged care must be familiar with the Guiding Principles for Medication Management in Residential Aged Care Facilities, which outlines recommendations for medication management in residential aged care settings based on current best practices (DoHaAC 2022).

What is Medication Scheduling?

Read: Drug Scheduling: Understanding the Basics

Scheduling is the classification system used in Australia to regulate the availability of medicines and poisons. Medicines and poisons are classified into 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 2023; 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 2022).

schedule 8 medicines pharmacist filling prescription
Scheduling is the classification system used in Australia to regulate the availability of medicines and poisons.

What are Schedule 8 Medicines?

Schedule 8 medicines are ‘controlled drugs’ that must meet specific conditions when 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).

Medicines that are classified as Schedule 8 include, but are not limited to:

  • Opioid analgesics, including:
    • Buprenorphine
    • Codeine
    • Cannabis*
    • Fentanyl
    • Hydromorphone
    • Methadone
    • Morphine
    • Oxycodone
    • Oxycodone with naloxone
    • Pethidine
    • Tapentadol
  • Stimulants, including:
    • Dexamfetamine
    • Lisdexamfetamine
    • Methylphenidate
  • Ketamine
  • Benzodiazepines (flunitrazepam and alprazolam)
  • Cocaine.

(Poisons Standard February 2024)

* Note: For more information on the scheduling of cannabis, tetrahydrocannabinol and cannabidiol, see: https://www.tga.gov.au/products/unapproved-therapeutic-goods/medicinal-cannabis-hub/medicinal-cannabis-access-pathways-and-patient-access-data

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 (DoHaAC 2019).

Real-time monitoring programs such as SafeScript in Victoria, Drugs and Poisons Information System Online Remote Access (DORA) in Tasmania, SafeScript NSW, ScriptCheck SA, ScriptCheckWA, Qscript in Queensland and Canberra Script are being used to identify overuse, fraudulent behaviour and ‘doctor shopping’. This occurs when an individual attempts to illicitly obtain medicine from multiple practitioners simultaneously (Health.vic 2023a; 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 as '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 3 deaths related to opioid use (TGA 2021).

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
  • One-third (30%) of those taking opioids considered themselves dependent.

(TGA 2021)

schedule 8 medicines opioids
Every day, there are about 150 hospitalisations, 14 emergency department admissions and three deaths related to opioid use in Australia.

As a result of this research, there have been many changes implemented by TGA, including:

  • Smaller pack sizes for immediate-release prescription opioids to reduce the circulation of unused opioids in the community.
  • Sponsors are required to include boxed warnings and class statements in the Product Information (PI) documents for all prescription opioids about their potential for harmful and hazardous use.
  • Safety information, including relevant warnings, is prominently displayed in the Consumer Medicines Information (CMI). This aims to ensure that language and information remain consistent across all prescription opioid classes.
  • Indications in the PI documents for immediate release and modified release products reinforce that opioids should only be used when other analgesics are not appropriate or have been proven ineffective.
  • Hydromorphone and fentanyl modified release products are contraindicated for ‘opioid naive patients’, i.e. those who do not already use opioids regularly.
  • There are stronger restrictions on the use of fentanyl, which is one of the strongest opioids available in Australia.
  • There is increased education for both prescribers and consumers.

(TGA 2021)

Prescribing Schedule 8 Medicines

Depending on the state or territory in which they are operating, the prescriber may need to obtain a permit to prescribe a Schedule 8 medicine. The exact requirements, including who can prescribe and how long they can prescribe for, will depend on the jurisdiction and the patient’s medical diagnosis. PBS regulations have also changed to reduce opioid prescribing. Regulations for hospitals and private hospitals differ from those for residential aged care facilities.

A pharmacist cannot 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.

In July 2022, the Federal Government implemented an eNRMC (Electronic National Residential Medication Chart) Transitional Arrangement, allowing residential aged care services, prescribers and pharmacists to use Transitional eNRMC Products for PBS medication chart prescribing, dispensing and administration (DoH 2022). For more information, see: https://www.health.gov.au/sites/default/files/documents/2022/06/electronic-national-residential-medication-chart-enrmc-transitional-arrangement-prescriber-information-pack.pdf

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 (Health.vic 2023b).

Possessing Schedule 8 Medicines

It is a criminal offence to possess a Schedule 8 medicine unless authorised. 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 (Health.vic 2023b).

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 (Health.vic 2023b).

Administering Schedule 8 Medicines

schedule 8 medicines nurse administering medicine

In Victorian residential aged care facilities, a registered nurse must manage Schedule 8 (and Schedule 4) medicine administration in adherence to 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 and endorsed enrolled nurses. Personal care workers can only administer medications from a Dose Administration Aid.

When administering a Schedule 8 medicine, the nurse must refer to either:

  • Written directions from a medical practitioner or nurse practitioner (or other authorised practitioner)
  • In the case of an emergency, oral instructions from a medical practitioner or nurse 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 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 a locked storage facility that is fixed to a floor or wall (Health.vic 2021).

Steel medicine cabinets are strongly recommended for medicines that are 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.

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.

Imprest Systems

In Victoria, these require a permit from the Department of Health and Human Services, an approved list of drugs and strict protocols for ordering, administration and record-keeping. For more information, see: https://www.health.vic.gov.au/drugs-and-poisons/residential-aged-care-medicine-storage-and-record-keeping

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
  • Hoard medicines
  • 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 2023; 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


References


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