POISONS SCHEDULING. Monique Reyes Senior Pharmaceutical Officer Pharmaceutical Regulatory Unit NSW Ministry of Health

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1 POISONS SCHEDULING Monique Reyes Senior Pharmaceutical Officer Pharmaceutical Regulatory Unit NSW Ministry of Health

2 Topics Schedules of the Poisons Standard (Cth) Poisons and Therapeutic Goods Act 1966 (NSW) Drug Misuse and Trafficking Act 1985 (NSW) Licences & Authorities

3 Poisons Standard aka SUSMP (Standard for the Uniform Scheduling of Medicines and Poisons) Scheduling is a national classification system for controls on how medicines and chemicals are made available to the public, and other restrictions on their supply and use. Medicines and chemicals are classified into Schedules according to the level of regulatory control over the availability of the medicine or chemical, required to protect public health and safety.

4 Schedules Schedule 1 Schedule 2 Schedule 3 Schedule 4 Schedule 5 Schedule 6 Schedule 7 Schedule 8 Schedule 9 Schedule 10 Not currently in use Pharmacy Medicine Pharmacist Only Medicine Prescription Only Medicine OR Prescription Animal Remedy Caution Poison Dangerous Poison Controlled Drug Prohibited Substance Substances of such danger to health as to warrant prohibition of sale, supply and use

5 Restriction on access and availability Schedule 9 Schedule 10 Schedule 8 Schedule 4 Schedule 7 Schedule 3 Schedule 2 Schedule 6 Schedule 5 Prohibited Substance Substances of such danger to health as to warrant prohibition of sale, supply and use Controlled Drug Prescription Only Medicine OR Prescription Animal Remedy Dangerous Poison Pharmacist Only Medicine Pharmacy Medicine Poison Caution

6 Poisons Schedule 5: Caution Substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label, such as "CAUTION - KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS BEFORE OPENING OR USING". Schedule 6: Poison Substances with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warnings and safety directions on the label, such as "POISON - KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS BEFORE OPENING".

7 Poisons Schedule 7: Dangerous Poison Substances with a high potential for causing harm at low exposure and which require special precautions during manufacture, handling or use. These poisons should be available only to specialised or authorised users who have the skills necessary to handle them safely. Special regulations restricting their availability, possession, storage or use may apply. Schedule 10: Substances of such danger to health as to warrant prohibition of sale, supply and use - Substances which are prohibited for the purpose or purposes listed for each poison.

8 Medicines Schedule 2: Pharmacy Medicine Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person. Schedule 3: Pharmacist Only Medicine Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.

9 Medicines Schedule 4: Prescription Only Medicine, or Prescription Animal Remedy Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription. Schedule 8: Controlled Drug Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.

10 Medicines/Poisons Prohibited Substance Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.

11 Derivatives of listed substances Schedule entry includes any concentration of all salts and derivatives of the poison unless it specifically states otherwise Similar in nature structurally, pharmacologically, and toxicologically Readily converted either physically or chemically to a scheduled poison There is no authority, other than the Courts, to determine the schedule of a substance that is not explicitly scheduled.

12 Exemptions to Scheduling Appendix A: general exemptions e.g. food, human blood products, radioisotopes for therapeutic use, in-vitro diagnostic analytical preparations (< 0.001% of an S1-S8) Appendix B: considered not to require control by scheduling e.g. ALCOHOL, DEHYDRATED Reason: Use pattern restricts hazard Area of use: Human therapeutic use Appendix G: dilute preparations - concentration cut-offs for specified poisons, where the Standard does not apply. Additionally, S1 to S6<10mg/L not scheduled

13 Advisory Committee on Scheduling Advisory Committee on Medicines Scheduling (ACMS) was established to advise and make recommendations to the Secretary of the Department of Health (or delegate) on the level of access required for medicines and in some instances chemicals Advisory Committee on Chemical Scheduling (ACCS) is the chemical counterpart Scheduling Policy Framework

14 Poisons and Therapeutic Goods Act 1966 NSW legislation Adopts Schedules 1 to 9 of the Poisons Standard, and interpretation provisions Regulates Schedule 10 Adopts packaging and labelling requirements of Standard Gives effect to Appendices A, B, F & K

15 NSW Licences and Authorities Licence to Supply by Wholesale of S2, S3, S4 and S8 Licence to Manufacture of S8 Authority to possess (but not supply) S8 for the purpose of analysis, research or instruction Authority to possess, use, manufacture or supply S9 for medical or scientific research, analytical, teaching or training purposes or for industrial or commercial purposes Authority to use, manufacture or supply S10

16 Drug Misuse and Trafficking Act 1985 Schedule 1 consists of substances in Schedule 4, Schedule 8, Schedule 9 of the SUSMP, and plants Provides for offences for possession, manufacture and supply of Schedule 1 DMTA and Schedule 9 of Standard Provides for offences for manufacture, supply and advertising of new psychoactive substances Provides for authority to possess, manufacture and supply Schedule 1 DMTA for the purpose of scientific research, instruction, analysis or study Relationship with Poisons and Therapeutic Goods Act

17 THE END Questions?

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