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Important changes to pseudoephedrine and naloxone

Start using ProjectSTOP® or stop selling Pseudoephedrine

From 23 March 2016 it will be mandatory for all pharmacists to record the details of sales of over-the-counter packs of pseudoephedrine from NSW community pharmacies, in an online, real-time electronic system, at the time of supply.

The electronic recording of pseudoephedrine sales must be in a system that meets specific criteria. The only software program that currently meets these criteria is ProjectSTOP®.

The Pharmacy Guild of Australia (NSW Branch) has been engaged by the NSW Ministry of Health  to assist community pharmacies to access ProjectSTOP®, and to provide training on its use.

More information on the new requirements can be found here.

Naloxone – Schedule 3

As of 1 February 2016, Naloxone is a Schedule 3 substance when used for the treatment of opioid overdose.

Schedule 3 medicines generally do not require a pharmacist's dispensing label (unless re-packed) as they are labelled as Schedule 3 pharmacist only medicines with full consumer directions. However currently marketed packs of naloxone are labelled "PRESCRIPTION ONLY MEDICINE" (Schedule 4) and are not labelled with any consumer directions. Consequently, pharmacists supplying naloxone without prescription will need to over-label it with a full dispensing label- patient name, directions, date, etc. as per Appendix A of the Poisons and Therapeutic Goods Regulation 2008.

As currently marketed packs of naloxone do not include a hypodermic needle, pharmacists supplying it will need to supply 23 gauge needle/s at the same time.

Pharmacists should check for professional practice guidelines on appropriately managing supply of naloxone.

Not sure what to do?

If you have any questions about these changes, contact the Duty Pharmaceutical Officer, Pharmaceutical Services Unit by telephone on 9391 9944, or by email at pharmserv@doh.health.nsw.gov.au