Applying the poisons legislation – practical tips

In this section of the newsletter we will help you apply the poisons legislation in your practice. Each newsletter will include explanations, guidance, tips and resources relating to one or more of the common areas where the Council sees that practitioners have difficulties or experience confusion.

This month’s newsletter covers the special requirements associated with Schedule 4 medications which are listed in Appendices B and D, commonly known as S4D and S4B medications.
 

Schedule 4, Appendix D and Appendix B

The official term for Schedule 4 medications as used in the NSW Poisons and Therapeutic Goods Regulation 2008 is restricted substances. Within the overall classification of restricted substances, the Regulation also refers to prescribed restricted substances and special restricted substances. Prescribed restricted substances are those S4 items listed in Appendix D of the Regulation and special restricted substances are those S4 items listed in Appendix B of the Regulation. For convenience, we usually refer to them as S4D and S4B substances respectively.

The relationship between these types of restricted substances is as follows: S4Ds are a subset of all S4s, and S4Bs are a subset of S4Ds. In other words, any S4B is also by definition an S4D; however, not all S4Ds are also S4Bs.

Lists of the substances in Appendices B and D can be found in the NSW Poisons and Therapeutic Goods Regulation 2008, and also on the NSW Health website at https://www.health.nsw.gov.au/pharmaceutical/Pages/sch4d.aspx#bookmark1 (Appendix D) and https://www.legislation.nsw.gov.au/#/view/regulation/2008/392/appb (Appendix B).

Generally speaking, Appendix B includes a number of barbiturates and anabolic androgenic steroids. Appendix D includes the substances in Appendix B, together with benzodiazepines, growth hormones and peptides and a range of recent additions which are considered to require additional controls because of their potential for misuse and diversion.
 

Summary of legal requirements

Both S4Ds and S4Bs are subject to different and/or additional legal requirements to S4s which are not listed in the two Appendices. These are most easily outlined using the following table.

 

Schedule 4

Prescribed restricted substances (S4D)

Special restricted substances (S4B)

Valid for

12 months

6 months

Supply on image based prescription

Yes

No

Repeat intervals required if repeats ordered

No

Yes

Repeats must be retained at original pharmacy

No

Yes (stored with repeats for Schedule 8 substances)

Cancelled prescriptions must be retained at original pharmacy

No

Yes (stored with cancelled prescriptions for Schedule 8 substances)

Loss or theft must be reported to NSW Health

No

Yes

Available on emergency prescription authorised by prescriber

Yes

Available as emergency supply without authorisation by prescriber

If meets criteria* listed in clause 45 of the Regulation

No

Apparently forged prescriptions must be reported to police

No

Yes

Storage

Dispensary or other area away from public access

Community/hospital pharmacies: Dispensary or other area away from public access

Hospital wards: together with Schedule 8 substances

 

* These criteria are that

  1. the person is undergoing treatment essential to the person’s well-being, and

  2. the substance has previously been prescribed for the treatment, and

  3. the person is in immediate need of the substance for continuation of the treatment, and

  4. in the circumstances, it is not practicable for the person to obtain a prescription for the substance from an authorised practitioner.

You should note that the table is a summary only, and you should ensure that you are very familiar with the information on the NSW Health website available though the links listed above.