S2 + S3 legislation

• Scheduling


  National classification system that controls how medicines and chemicals are made available to the public

  
• Scheduling


  • Classified into schedules according to the level of regulatory control over the availability of the medicine or poison
  • Aims to balance timely and convenient need for access with risks of use
• Schedules


  • Published in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP or Poisons Standard)
  • Given legal effect through state and territory legislation

  
• Up-scheduling


  Medicine or chemical is moved from a less restrictive to a more restrictive schedule
• Down-scheduling


  Medicine or chemical is moved from a more to a less restrictive schedule
• Scheduling committees


  1. 2 committees advise and make recommendations to minister

  2. Advisory Committee on Medicines Scheduling (ACMS)

  3. Advisory Committee on Chemicals Scheduling (ACCS)

  4. Meet 3 times a year (March, June and September)

  5. Anyone can apply to change the schedule of a medicine
• Scheduling changes EXAMPLE 1: Paracetamol


  • Reduce maximum pack size available for general sale
  • Reduce maximum pack size available in pharmacies without supervision
  • Make other pack sizes available only under pharmacist supervision
• Changes intended to minimise incidence and harm from intentional paracetamol self-poisoning while maintaining appropriate access to paracetamol for treatment of pain
• Scheduling changes EXAMPLE 2: Naloxone


  • Changed from prescription only to pharmacist only medicine
• 96 stakeholder submissions all supported down scheduling of naloxone
• TGA's rationale for decision: Naloxone is a well-tolerated life-saving medicine with minimal adverse effects, and the benefits outweigh the risks
• Using the SUSMP to determine the schedule of a product


  1. Start at the index and look up substance of interest

  2. Check information in all listed schedules

  3. Logical process of decision-making about which schedule
• Preparations containing poisons listed in 2 or more schedules

  
• NSW legislation: Poisons and Therapeutic Goods Act 1966 (PTGA) and Poisons and Therapeutic Goods Regulation 2008 (PTGR)

  
• Parts of the Poisons and Therapeutic Goods Regulation


  • Part 1- Preliminary
  • Part 2- Poisons (schedules 1, 2, 3, 5, 6 and 7)
  • Part 3- Restricted substances (schedule 4)
  • Part 4- Drugs of addiction (schedule 8)
  • Part 4B- Etorphine
  • Part 4C- Schedule 10 substances
  • Part 5- Supply by wholesale
  • Part 6- Preparation, handling, supply and labelling of therapeutic goods
  • Part 7- Analysis and disposal of seized goods
  • Part 8- Licenses and authorities
  • Part 8A- Real time prescription monitoring
  • Part 9- Miscellaneous
  • Appendices- A, B, C, D, E

  
• Navigating the Regulation


  1. Part 2, 3, 4 - Schedules 1, 2, 3, 4, 5, 6, 7, 8

  2. Division 1 - Packaging and labelling

  3. Division 2 - Storage

  4. Division 3 - Prescriptions

  5. Division 4 - Supply

  6. Division 5 - Records of supply

  7. Division 6 - Miscellaneous

  8. Division 7 - Administration, Miscellaneous
• Storage


  • Store apart from food and in such a way that they are unable to contaminate food if they spill, break open, etc.
  • Additional requirement for S3s: Room or enclosure to which the public does not have access
• Packaging and Labelling


  1. Dealers must label according to SUSMP

  2. Exception for re-packaging for convenience of patients

  3. Truth in labelling

  4. Labelling of S3s must have dealer's name and address
• Prescriptions


  1. Not needed but can be written

  2. Only pseudoephedrine prescriptions need to be written as if S4

  3. Quantity and purpose must be appropriate
• Prescriptions, Supply requirements differ for S2, S3, S4, S8 medicines
• Packaging


  • A way that they are unable to contaminate food if they spill, break open, etc.
  • Additional requirement for S3s in clause 12
  • Room or enclosure to which the public does not have access
• Clause 7: Packaging


  • Dealers must label according to SUSMP
  • Exception is made for re-packaging for convenience of patients
• Clause 9: Labelling of S3s


  • Must have dealer's name and address
  • Includes supply by pharmacists
  • Does not apply to wholesalers
• Clause 14: Prescriptions


  Not needed but can be written
• Clause 15: Prescriptions


  Only pseudoephedrine prescriptions need to be written as if S4

  
• Clause 16: Prescriptions


  Quantity and purpose must be appropriate

  
• What constitutes appropriate quantity and purpose?
• What is NOT appropriate quantity and purpose?
• What do you do if you receive requests which are for INAPPROPRIATE quantity and purpose?
• Chloramphenicol


  For ophthalmic use only
• Fluconazole


  In single dose oral preparations containing 150mg or less for the treatment of vaginal candidiasis
• Melatonin


  • In modified release tablets containing 2 mg or less for the short-term treatment of primary insomnia for adults aged 55 or over, in packs containing not more than 30 tablets
  • In immediate release preparations containing 5 mg or less for the treatment of jet lag in adults 18 years and over, in a primary pack containing no more than 10 dosage units
• Metoclopramide


  When combined with paracetamol in divided preparations, packed and labelled only for the treatment of nausea associated with nausea, in packs containing not more than 10 dosage units
• Thorough history taking is needed to comply with the law!
• Clause 18: Schedule 3 Supply by Pharmacists


  • Personally handing substance to person
  • Giving person an opportunity to seek advice regarding use of substance (dosage, frequency of administration, general toxicity)

  
• Who is a pharmacist?
• What does personally hand mean?
• What does opportunity to seek advice mean?
• Clause 24: Schedule 3 Recordable (S3R)


  • If supplied on prescription, recording of details as outlined in cl55
  • If not in prescription, recording of details in an approved electronic form (unique reference number, name of person supplying, name/address of person to whom supplied, name, strength and quantity of pseudoephedrine item supplied, date of supply, identification details of person to whom supplied)

  
• NSW digital driver's licences are acceptable forms of photo ID