AHMAC - Scheduling policy framework for medicines and chemicals
Chapter 3: Classification of medicines and chemicals into the schedules
1. Principles of scheduling
The Scheduling Policy Framework supports the broader public health policy frameworks in Australia both for the quality use of human medicines and safe use of chemicals.
For the quality use of human medicines, which incorporates the selection of appropriate therapeutic management options, appropriate choice of medicines (where a medicine is considered necessary) and safe use; the scheduling classification underpins the need for particular healthcare professionals to be involved in the supply of certain medicinal substances in order to promote safe and quality use. Labelling with specific phrases (signal heading) emphasises this need for intervention by particular health professionals. The scheduling decision involves consideration of a number of factors such as the toxicity of the substance, diagnosis and the purpose of use, potential for abuse, safety in use and the need for access to the substance.
The SPF also supports safer use of agricultural, veterinary and domestic chemical products through labelling with specific "alert" phrases keyed to the major threat level or phrases emphasising the need for intervention by particular professionals (where warranted) (signal headings). Where necessary the scheduling of certain veterinary chemicals reinforces the need for intervention by veterinary practitioner to promote safe use. The scheduling decision involves consideration of a number of factors including the toxicity of the substance, purpose of use, potential for abuse, safety in use, the need for specialist training or personal protective equipment for safe or effective use, and the need for access to the substance.
The SUSMP also establishes the required packaging and all necessary label information for the safe use of domestic chemical products.
1.1 The schedules
Substances can be classified into schedules as follows:
- Schedule 1 is currently not in use.
- Schedules 2, 3, 4, and 8 include medicinal substances intended for human therapeutic use and have increasingly restrictive regulatory controls on their availability in the order stated.
- Schedules 4, 5, 6, 7 and 8 include poisons, with increasingly strict special regulatory controls on the availability of the poisons listed in Schedules 4, 7 and 8. Veterinary medicines are not included in Schedule 3. A limited number of veterinary medicines are included in Schedule 2. However, these entries are being phased out.
- Schedule 9 includes substances that should be available only for medical or scientific research including clinical trials conducted with the approval of Commonwealth and/or state/territory health authorities. Otherwise, the possession, use, sale or supply of substances in Schedule 9 is in general prohibited.
- Schedule 10 includes poisons of such danger to health as to warrant prohibition of sale, supply and use.
The numbering of Schedules 2, 3, 4, and 8 signifies an increasing level of professional healthcare intervention combined with increasingly stricter restrictions on availability. For Schedules 5, 6 and 7 the numbering signifies increasingly stricter container and labelling requirements. Appendix J may also include additional special controls on availability, use of specialist equipment and training of users.
1.2 The cascading principle
The model for making scheduling decisions embodies a "cascading principle".
For medicines, a substance is first assessed using the factors for Schedule 8. If the factors for Schedule 8 are not applicable, the substance is assessed against the Schedule 4 factors and if not applicable, against the Schedule 3 factors, and if not applicable, against the Schedule 2 factors.
Other substances are first assessed using the factors for Schedule 9, however the highly restricted criteria for this schedule mean that very few substances are likely to be considered for, or included in this schedule. If the factors for Schedule 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.
For veterinary chemicals, assessment 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.
The cascading principle also applies to substances that are both medicines and chemicals. Consideration is given to the therapeutic and non-therapeutic use of the substance and its toxicity. Assessment is made against the factors for Schedule 7 and the factors for Schedule 8, and where these are not relevant, "cascading" to Schedules 6 and 4 respectively and so on through Schedules 5, 3, and 2 (where relevant).
Exemption from scheduling requirements (Appendix B) is appropriate where the substance does not meet the factors for ANY schedule. The decision can only be made by exclusion; that is, there are no factors as such for exemption from the Schedules. An exemption may be recorded as:
- a general exemption where warranted;
- an exemption for a class of products in Appendix A (see above);
- a specific exemption from the SUSMP for the substance in Appendix B; or
- an exemption from an entry in a Schedule.
An exemption may be subject to conditions including, but not limited to, the maximum concentration, use, labelling, packaging and pack size restrictions.
This model exemplifies the cautionary principle for public health, allows the best fit to be found using a systematic approach and also facilitates the reclassification process for substances when new knowledge or practice emerges that materially alters the public health risk or when an application for rescheduling is received.
2. The scheduling factors
In order to ensure that public health objectives are consistently met, all scheduling decisions include consideration of a standardised set of "factors". Factors rather than criteria are considered to be more appropriate assessment tools, as:
- 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 in turn may influence the final classification;
- there is interaction between the various factors such that a particular grouping of factors may suggest one classification where taken individually they may not; and
- the factors must be considered as a whole in determining the public health risk for the proposal, not applying any particular order of consideration or weight to any one factor. This reflects the final assessment for each scheduling proposal, of relative public health risk against the classification spectrum.
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 are not significant as scheduling decisions are made on balance of the available evidence. In this respect, there is no inherent or substantive difference between the scheduling of medicines and chemicals.
2.1 Risk/benefit analysis
Consideration of these factors permits the objective assessment of the risk/benefit balance for the consumer at different levels of access and therefore optimal public availability. In considering the risk it is necessary to define the hazards and then determine what action is necessary in terms of the amount of regulatory intervention required to reduce the public health risk to an acceptable level. The following questions should be answered to ensure that the risk is understood as completely as possible:
- What is the hazard?
- How widespread is the hazard?
- In what circumstances will the hazard arise?
- What is the likelihood of the hazard occurring?
- Who or what is at risk?
- What are the consequences of the hazard in terms of severity (morbidity and mortality) and duration?
The Schedules in the SUSMP comprise lists of substances (entries) all of which are subject to the conditions and requirements for that Schedule which are set out in Parts 2, 3 and 4 of the SUSMP. The Schedules are compilations of varying levels of risk treatments available to reduce the assessed public health risk to an acceptable level. What the substance refers to in the schedule entry will vary according to the interpretation of "substance" in subsection 1(2) in Part 1 of the SUSMP.
Factors for pharmacy medicines (schedule 2)
- The quality use of the medicine can be achieved by labelling, packaging, and/or provision of other information; however access to advice from a pharmacist is available to maximise the safe use of the medicine.
The medicine is for minor ailments or symptoms that can easily be recognised and are unlikely to be confused by the consumer with other more serious diseases or conditions. Treatment can be managed by the consumer without the need for medical intervention. However, the availability of a pharmacist at the point of sale supports the consumer in selecting and using the appropriate medicine.
- The use of the medicine is substantially safe for short term treatment and the potential for harm from inappropriate use is low.
Suitable for diagnosis and treatment by the consumer in the management of minor ailments.
- The use of the medicine at established therapeutic dosage levels is unlikely to produce dependency and the medicine is unlikely to be misused, abused or illicitly used.
Medicines which do not meet this factor, are not suitable to be classified as Schedule 2 Pharmacy Medicines, irrespective of any other applicable factors.
- The risk profile of the medicine is well defined and the risk factors can be identified and managed by a consumer through appropriate packaging and labelling and consultation with a medical practitioner if required.
There is a low and well-characterised incidence of adverse effects; interactions with commonly used substances or food and contra-indications.
- The use of the medicine at established therapeutic dosage levels is not likely to mask the symptoms or delay diagnosis of a serious condition.
Appropriate labelling and packaging can manage any risks.
Factors for pharmacist only medicines (schedule 3)
- The medicine is substantially safe with pharmacist intervention to ensure the quality use of the medicine. There may be potential for harm if used inappropriately.
The consumer can identify the ailments or symptoms that may be treated by the medicine but counselling and verification by a pharmacist is required before use. Pharmacist-consumer dialogue is necessary to reinforce and/or expand on aspects of the safe use of the medicine.
- The use of the medicine at established therapeutic dosages is not expected to produce dependency. Where there is a risk of misuse, abuse or illicit use identified, the risk can be minimised through monitoring by a pharmacist.
- The risk profile of the medicine is well defined and the risk factors for adverse effects and interactions are known, identifiable and manageable by a pharmacist.
- Where the medicine is intended for recurrent or subsequent treatment of a chronic condition, pharmacist intervention is required to monitor safe use of the medicine following recommendation by a medical practitioner or a pharmacist.
The consumer may not be able to self-monitor the safe ongoing use of the medicine. The condition does not require medical diagnosis or only requires initial medical diagnosis, and the consumer does not require close medical management.
- The use of the medicine at established therapeutic dosage levels may mask the symptoms or delay diagnosis of a serious condition.
Pharmacist-consumer dialogue is required to detect the risk of masking a serious disease or compromising medical management of a disease, and to deal with it appropriately.
Factors for prescription only medicines and prescription animal remedy (schedule 4)
- The ailments or symptoms that the substance is used for require medical, veterinary or dental intervention2.
Diagnosis, management or monitoring of the medical condition is such that it requires medical, veterinary or dental intervention before the substance is used.
- The use of the substance requires adjunctive therapy or evaluation.
Adjunctive therapy could include other medicines, non-pharmacological measures, or specialised medicine delivery devices. Evaluation could include laboratory tests or additional clinical assessments.
- The use of the substance at established therapeutic dosage levels may produce dependency but has a moderate propensity for misuse, abuse or illicit use.
Control of access and duration of therapy by a medical, veterinary or dental practitioner is required.
- The seriousness, severity and frequency of adverse effects are such that monitoring or intervention by a medical, veterinary or dental practitioner is required to minimise the risk of using the substance.
- The margin of safety between the therapeutic and toxic dose of the substance is such that it requires medical, veterinary or dental intervention to minimise the risk of using the substance.
- The seriousness or severity and frequency of the interactions of the substance (medicine-medicine, medicine-food, or medicine-disease) are such that monitoring or intervention is required by a medical, veterinary or dental practitioner.
- The use of the substance has contributed to, or is likely to contribute to, communal harm.
For example the development of resistant strains of microorganisms. Appropriate use, and/or the decision to continue treatment, requires evaluation by a medical, veterinary or dental practitioner.
- The experience of the use of the substance under normal clinical conditions is limited.
Unexpected effects of the substance may only become evident after widespread use. Close monitoring of the patient is required by a medical, veterinary or dental practitioner to monitor for unanticipated effects.
Factors for label use of "Warning" (schedule 5)
- The substance is non-corrosive and has a low toxicity.
Acute oral toxicity (rat) is between 2000 mg/kg - 5000 mg/kg. Acute dermal LD50 is more than 2000 mg/kg. Acute inhalation LC50 (rat) is more than 3000 mg/m3 (4 hours).
Dermal irritation is slight to moderate. Eye irritation is slight to moderate. Immediate, prolonged or repeated contact with the skin or mucous membranes may cause slight to moderate inflammation. Skin sensitisation is slight or nil.
- The substance has a low health hazard.
The substance presents a low hazard from repeated use and is unlikely to produce irreversible toxicity. There is no other significant toxicity (e.g. respiratory sensitisation, mutagenicity, carcinogenicity, reproductive toxicity etc).
- The substance is capable of causing only minor adverse effects to humans in normal use.
Specialised equipment should not be necessary for safe use.
- The likelihood of injury in handling, storage and use can be mitigated through appropriate packaging and simple label warnings.
Adequate packaging and labelling protects the consumer from the known danger(s) of the substance if it is inhaled, taken internally or if it penetrates the skin. Potential harm is reduced through labelling which informs the consumer about the safety measures to apply during handling and use (including safety directions) and child resistant packaging (where appropriate).
- The substance has a low potential for causing harm.
Potential harm is reduced through the use of appropriate packaging with simple warnings and safety directions on the label.
Factors for label use of "Poison" (schedule 6)
- The substance has a moderate to high toxicity, which may cause death or severe injury (including destruction of living tissue) if inhaled, taken internally, or in contact with skin or eyes.
Acute oral LD50 (rat) is between 50 mg/kg - 2000 mg/kg. Acute dermal toxicity is between 200 mg/kg and 2000 mg/kg. Acute inhalation LC50 (rat) is between 500 mg/m3 and 3000 mg/m3 (4 hours).
Dermal irritation is severe. Eye irritation is severe. Skin sensitisation is moderate to severe.
- The substance has a moderate health hazard.
The substance presents a moderate hazard from repeated use and moderate risk of producing irreversible toxicity.
- Reasonably foreseeable harm to users can be reduced through strong label warnings, extensive safety directions and child-resistant packaging (where appropriate).
Adequate packaging and labelling protects the consumer from the known danger(s) of the substance. Potential harm is reduced through labelling which informs the consumer about the safety measures to apply during handling and use (including safety directions) and child resistant packaging.
- The substance has a moderate potential for causing harm.
Potential harm is reduced through the use of distinctive packaging with strong warnings and safety directions on the label.
Factors for dangerous poisons (schedule 7)
- The substance has a high to extremely high toxicity.
Acute oral LD50 (rat) is 50 mg/kg or less. Acute dermal LD50 is 200 mg/kg or less. Acute inhalation LC50 (rat) is 500 mg/m3 (4 hours) or less. Dermal irritation is corrosive. Eye irritation is corrosive.
- The substance has a high health hazard.
The substance presents a severe hazard from repeated and unprotected use or a significant risk of producing irreversible toxicity, which may involve serious, acute or chronic health risks or even death if it is inhaled, taken internally or penetrates the skin.
- The dangers of handling the poison are such that special precautions are required in its manufacture, handling or use.
The dangers associated with handling the substance are too hazardous for domestic use or use by untrained persons and warrant restrictions on its availability, possession or use.
- The substance has a high potential for causing harm at low exposure.
The substance should be available only to specialised or authorised users who have the skills necessary to handle the substance safely. Restrictions on their availability, possession, storage or use may apply.
For schedules 5, 6 and 7 the following definitions apply:
- Slight: no corneal opacity
- Moderate: corneal opacity, reversible 7 days
- Severe: corneal opacity not reversible 7 days
- Corrosive: irreversible tissue damage in the eye following application of a test substance to the anterior surface of the eye
- Slight: slight irritation at 72 hours
- Moderate: moderate irritation at 72 hours
- Severe: severe irritation at 72 hours
- Corrosive: irreversible tissue damage in the skin following application of a test substance
Factors for controlled drugs (schedule 8)
- The substance is included in Schedule I or II of the United Nations Single Convention on Narcotic Drugs 1961 or in Schedule II or III of the United Nations Convention on Psychotropic Substances 1971.
- The substance has an established therapeutic value but its use, at established therapeutic dosage levels, is recognised to produce dependency and has a high propensity for misuse, abuse or illicit use.
- The substance has an established therapeutic value but by reason of its novelty or properties carries a substantially increased risk of producing dependency, misuse, abuse or illicit use.
Factors for prohibited substances (schedule 9)
- The substance is included in either Schedule IV to the United Nations Single Convention on Narcotic Drugs, 1961 or in Schedule I to the United Nations Convention on Psychotropic Substances 1971.
- The substance has either no currently established therapeutic value, or taking into consideration the danger to the health of individuals and of the community (both immediate and imminent) associated with the use of the substance as compared to the therapeutic advantages of the substance, the benefits are substantially outweighed by the risks.
Dangers are such to warrant limiting use to strictly controlled medical and scientific research.
- The substance has no currently established therapeutic value and is likely to present a high risk of dependency, abuse, misuse or illicit use.
A high level of control is required through prohibition of use, possession, administration, prescription, sale or distribution to prevent abuse, misuse or diversion into illicit activities.
Factors for substances of such danger to health as to warrant prohibition of sale, supply and use (schedule 10)
- The substance poses a potential public health risk as a result of its sale, possession or supply that requires management. The potential health risk does not include potential for abuse, diversion into illicit products or other factors which would warrant inclusion in Schedule 9.
- The substance has a public health risk that substantially outweighs the benefit to the extent that no Schedule would provide appropriate public access to any proposed or known products.
The Secretary may establish a cut-off from Schedule 10 where the substance no longer meets the factors for inclusion in this Schedule or in any other Schedule in the Poisons Standard.
- For the purposes of this document medical, veterinary or dental intervention is considered to include other authorised prescribers as described in relevant legislation of Australian states and territories.