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AHMAC - Scheduling policy framework for medicines and chemicals

Endorsed by AHMAC December 2017

18 January 2018

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The Scheduling factors

Version 1.0, January 2018

Section 52E of the Act sets out the general factors for scheduling consideration, in order to determine the relevant schedule for a substance, factors specific to each schedule need to be considered. These factors are a critical piece of scheduling policy and are intended to ensure consistency in the application of public health risk consideration when making a scheduling decision. This document sets out the factors for each schedule and the appendices.

Details regarding amendments to Parts 1-3 of the Poisons Standard are included in the Scheduling Handbook.

Factors for pharmacy medicines (schedule 2)

  1. 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 should be 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.

  2. 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.

  3. The use of the medicine is very unlikely to produce dependency (at either the established therapeutic dose or supratherapeutic doses) and the medicine is very 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.

  4. The risk profile of the medicine is well defined and the risks can be identified and managed by a consumer through appropriate packaging and labelling, including consultation with a health professional if directed by labelling.

    There is a low and well-characterised incidence of adverse effects; interactions with commonly used substances or food and contra-indications.

  5. 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)

  1. 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. Consumer consultation with a pharmacist is necessary to reinforce and/or expand on aspects of the safe use of the medicine.

  2. The use of the medicine is not expected to produce dependency at either the established therapeutic dose or at supratherapeutic doses. Where risk of misuse, abuse or illicit use is identified, the risk can be minimised through pharmacist-consumer consultation.
  3. The risk profile of the medicine is well defined and the risk factors for adverse effects, interactions and contraindications are known, identifiable and manageable by a pharmacist.
  4. 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 other authorised prescriber.

    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.

  5. The use of the medicine at established therapeutic dosage levels may mask the symptoms or delay diagnosis of a serious condition.

    Pharmacist-consumer consultation is required to detect the risk of masking a serious disease or compromising medical management of a disease, and to deal with it appropriately.

Note: Additional controls over access and training for substances in Schedule 3 may be required through inclusion in Appendix M, particularly where the potential for severe and possibly irreversible injury may occur without the user being aware of exposure and/or where the pattern of use of the substance poses a significant risk from direct or indirect public exposure.

Factors for prescription only medicines and prescription animal remedy (schedule 4)

  1. The ailments or symptoms that the substance is used for require medical, veterinary or dental intervention[1].

    Diagnosis, management or monitoring of the medical condition is such that it requires medical, veterinary or dental intervention before the substance is used.

  2. The use of the substance requires adjunctive therapy or evaluation or specialised handling for administration.

    Adjunctive therapy could include other medicines, non-pharmacological measures, or specialised medicine delivery devices. Evaluation could include laboratory tests or additional clinical assessments.

    For human medicines, a requirement for administration by injection will usually mean medical or dental supervision is required because of the additional risks and complexity of this route of administration.

  3. 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.

  4. 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.
  5. 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.
  6. 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.
  7. 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.

  8. 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.


Footnote

  1. For the purposes of the document medical, veterinary or dental intervention is considered to include other authorised prescribers as described in relevant legislation of Australian states and territories.

Factors for label use of "caution" (schedule 5)

  1. 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 weak or nil.

    When non-animal test data are used, validated test results meeting the following GHS categories are taken to meet the factors for this schedule: Acute toxicity Cat 5 (H303); Skin irritation Cat 3 (H316); Eye irritation Cat 2B (H320); Skin sensitisation Cat 1B (H317).

  2. 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).

  3. The substance is capable of causing only minor adverse effects to humans in normal use.

    Specialised equipment should not be necessary for safe use.

  4. 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).

  5. 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)

  1. 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.

    When non-animal test data are used, validated test results meeting the following GHS categories are taken to meet the factors for this schedule: Acute Toxicity Cat 3 or 4 (H301, H302, H311, H312); Skin irritation Cat 2 ( H315); Eye irritation Cat 2A-( H319); Skin sensitisation Cat 1A or Cat 1 (H317).

  2. The substance has a moderate health hazard.

    The substance presents a moderate hazard from repeated use and moderate risk of producing irreversible toxicity.

  3. 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.

  4. 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)

  1. 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.

    When non-animal test data are used, validated test results meeting the following GHS categories are taken to meet the factors for this schedule: Acute Toxicity Cat 1 or 2 (H300, H301, H310, H311); Corrosive Cat 1A. 1B, 1C ( H314); Eye damage Cat 1-( H318).

  2. 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.

  3. 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.

  4. 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.

Note: Additional controls over access and training for substances in Schedule 7 may be required through inclusion in Appendix J, particularly where the potential for severe and possibly irreversible injury may occur without the user being aware of exposure and/or where the pattern of use of the substance poses a significant risk from direct or indirect public exposure.

For Schedules 5, 6 and 7 the following definitions apply:

Eye irritation
Slight no corneal opacity
Moderate corneal opacity reversible within 7 days
Severe corneal opacity not reversible within 7 days
Corrosive irreversible tissue damage in the eye following application of a test substance to the anterior surface of the eye
Dermal irritation
Slight weak 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

In light of changes to animal testing acceptability and government regulations, alternative test data may be considered for scheduling consideration. The Scheduling Handbook provides additional guidance on acceptable tests for chemicals that may classified as Schedule 5, 6 or 7.

Factors for controlled drugs (schedule 8)

  1. 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.
  2. 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

Factors for prohibited substances (schedule 9)

  1. 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.
  2. 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 manufacture, possession, sale or use to prevent abuse, misuse or diversion into illicit activities.

    The benefits of use are substantially outweighed by the risks, and dangers are such as to warrant limiting use to strictly controlled medical and scientific research.

Note: High risk substances which do not have risks of dependency, abuse, misuse or illicit use should be included in Schedule 10.

Factors for substances of such danger to health as to warrant prohibition of sale, supply and use (schedule 10)

  1. The substance poses such a high public health risk, including potential risk, that its sale, supply and/or use require very strict control, with access generally being prohibited. The potential health risk does not include potential for abuse, diversion into illicit products or other factors which would warrant inclusion in Schedule 9.
  2. The substance has a public health risk that substantially outweighs the benefit to the extent that no other Schedule would provide appropriate public access to any proposed or known products. The serious public health risk may be restricted to particular uses.

    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.

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