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Scheduling handbook: Guidance for amending the Poisons Standard

Version 1.1, July 2019

30 July 2019

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Decisions on scheduling

Scheduling decisions involve a risk-benefit consideration in the context of protecting public health. This risk-benefit consideration takes into account factors such as those set out in section 52E of the Therapeutic Goods Act 1989 (CTH), including:

  • the toxicity of the substance
  • the purpose of use (including the diagnostic decision)
  • potential for abuse and misuse
  • safety in use, including the need for specialist training or personal protective equipment
  • the benefits/needs of access to the substance

Risk-benefit analysis

Scheduling is a regulatory intervention to reduce public health risk to an acceptable level. Therefore, the majority of the matters detailed in section 52E(1) of the Therapeutic Goods Act 1989 (CTH), as well as the assessment factors for each schedule, relate to risk rather than benefit. However, section 52E(1)(a) requires both risk and benefit from the use of a substance to be considered.

Consideration of the scheduling factors along with any other matters required by Section 52E(1) permits the objective assessment of the risk-benefit balance for the consumer at different levels of access and therefore optimal public availability.

Where a substance is proposed to be down-scheduled, performing a risk-benefit analysis using a value-tree framework tool may help determine whether the substance is a suitable candidate for supply at a particular scheduling level. The tool developed by Brass and others[1] may help identify potential risks to a down-scheduling proposal and provide an opportunity for applicants to include information to mitigate these risks.

Relevant benefits for a substance proposed to be down-scheduled are only in relation to public health outcomes.

The scheduling factors

All scheduling decisions include consideration of a standard set of factors, to ensure that public health objectives are consistently met and the application of public health risk considerations is consistent within each Schedule. The factors for each schedule are set out in the Scheduling Policy Framework and relate back to the matters required to be taken into account by section 52E(1) of the Therapeutic Goods Act 1989 (CTH).

A process using factors for each schedule allows a degree of judgement by reviewers to find the best fit for a substance in the classification system. The order in which the scheduling factors are listed is not significant, because scheduling decisions are made on balance of available evidence. This is the same for the scheduling of medicines and chemicals.

Factors are considered to be more appropriate than criteria as assessment tools, because:

  • each factor may exhibit a high degree of variability (rather than simply the presence or absence of the factor) and it is this variability that may influence the final classification
  • there is interaction between the various factors, such that a particular grouping of factors may suggest one classification, whereas taken individually they may not
  • in general, the factors are to be considered as a whole in determining the public health risk for the proposal. However, failing to meet one factor may preclude inclusion of the substance in that schedule. This reflects the final assessment of relative public health risk against the classification spectrum.

Other matters may also be taken into account when making a scheduling decision.

Amending Parts 1, 2 or 3 of the Poisons Standard

In making a decision to amend the introduction or Parts 1, 2 or 3 the Secretary considers:

  • the scope of the proposed provision (e.g. whether the provision applies to poisons that are not human medicines, or to all poisons)
  • the effect of the proposal on existing entries for poisons in the schedules and appendices
  • the regulatory need and justification for the change
  • the potential implications of the change for jurisdictions (e.g. compliance activities)

Amending the schedules (Part 4 of the Poisons Standard)

When considering a new substance application (i.e. a substance for which a scheduling decision has not already been made), the Secretary will consider whether to include the new substance in the schedules of the Poisons Standard based on the Scheduling factors set out in the Scheduling Policy.

If the substance is to be included in any Schedule, the Secretary will decide:

  • the name or description of the substance to be used
  • the scope of the entry and the schedule(s) in which the substance is to be included
  • which other parts of the Poisons Standard may also apply to the substance

Rescheduling applications are only made in relation to substances that have an existing (individual substance or class) entry or entries in the Poisons Standard.

When considering a rescheduling application the Secretary will decide:

  • the scope of the entry and the schedule(s) in which the substance is to be included
  • which other parts of the Poisons Standard may also apply to the substance

The cascading principle

The model for making scheduling decisions embodies a 'cascading principle'. This model exemplifies the precautionary principle for public health and allows the best fit to be found using a systematic approach. This approach also facilitates the reclassification process when new knowledge or practices emerge that materially alters the public health risk, or when an application for rescheduling is received.

Medicines

For medicines, a substance is first assessed against the factors for Schedule 10, 9 and 8. If those factors are not applicable, the substance is assessed against the Schedule 4 factors and if not applicable, against the Schedule 3 factors. If the Schedule 3 factors are not applicable, then it is assessed against the Schedule 2 factors.

Veterinary chemicals

Veterinary chemicals are assessed against the factors for Schedules 8 and 4 may be followed by assessment against Schedules 7, 6 and 5, as applicable. Veterinary chemicals will not be assessed against the criteria for Schedules 3 or 2.

Other chemicals

Other chemicals are first assessed using the factors for Schedules 10 and 9. However the highly restricted criteria for Schedule 9, relating to the propensity for dependence and abuse, means that very few substances are likely to be considered for, or included in, this schedule. If the factors for Schedules 10 or 9 are not applicable, the substance is assessed against the Schedule 7 factors, and if not applicable, against the Schedule 6 and then the Schedule 5 factors.

Substances that are both medicines and chemicals

The cascading principle also applies to substances that are both medicines and chemicals. A substance classified into Schedule 4 when used therapeutically, may appear in Schedules 5 and/or 6 and/or 7 when intended for non-therapeutic use, or for use in the treatment of animals.

Decisions not to schedule

Where a substance does not meet the factors for any schedule, it should, in the interests of transparency and consistency, be listed in Appendix B. Listing in Appendix B means a decision has been made to not schedule the substance. However, inclusion of a substance in Appendix B should not be used to infer that the substance is generally recognised as safe; in this context it has been found to not require scheduling on the balance of risk and benefit.

Exempted from scheduling

The term 'exempted from scheduling' is applicable where other forms of the same substance are listed in the schedule(s). This may include preparations of higher strength, of different pack size, for other indications or uses, in a different formulation or for use by different patient groups.

There are a number of mechanisms by which a substance, which appears in one or more schedules, is exempted from scheduling under certain defined circumstances. These mechanisms are:

  • A general exemption for substances in Schedules 1 to 6, at a concentration not exceeding 10 mg/kg
  • an exemption for a class of products through Appendix A
  • an exemption for a substance specific to the reason for its entry in Appendix B
  • an exemption for dilute preparations through Appendix G
  • an exemption for impurities in a pesticide at a concentration at or below the maximum content for that substance specified for that pesticide in the Standards for Active Constituents as published by the APVMA
  • a conditional exemption from within a Schedule

An exemption may be subject to conditions including, but not limited to, the maximum concentration, use, strength, dose, labelling, packaging and pack size restrictions.

In accordance with the cascading principle, exemption of a particular medicinal preparation to allow supply from general sales outlets (such as supermarkets) means that it does not meet the factors for Schedules 2, 3, 4 or 8. Medicinal preparations exempted from scheduling must be determined to be able to be supplied, with reasonable safety, without any access to health professional advice.

With reasonable safety

The term 'with reasonable safety' means:

  • the consumer is able to identify and self-manage the condition for which the medicine is intended without health professional input
  • the risk of the consumer confusing their condition with more serious diseases or conditions is very small
  • the risks to health from the medicine are small and can be managed with packaging and labelling. Risks to be assessed include, but are not limited to, risks from adverse reactions, drug/food interactions and contraindications
  • the risk of inappropriate use and misuse is negligible
  • there is little need to take any special precautions in handling
  • there is net public health benefit from wider availability for the consumer

Footnote

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