Over-the-counter medicines: S2 and S3

Semester 1, 2017

Background

Objectives (Overall)

  1. Understand the purpose and contents of the HDPR in the context of pharmacy practice
  2. Be able to navigate the HDPR
  3. Be able to determine how a pharmacist needs to practice to be in accordance with the law, especially with respect to dispensing controlled drugs and restricted drugs.
  4. Know key regulations for S2 and S3 (over-the-counter) medicines.

This section of the module…

We focus on objective 4:

Know key regulations for S2 and S3 medicines (i.e. over-the-counter medicines)

Key concepts

  1. Pharmacists need to be involved in the sale of an S3 medicine in a pharmacy. Pharmacy assistants can sell S2 medicines at a dispensary.
  2. S2 and S3 medicines must be stored in a place that is not accessible to the public.
  3. Pharmacists can only sell S3 poisons when the there is a therapeutic need and the purchaser is provided counselling on use of the medicine.
  4. There are additional regulations surrounding the sale of pseudoephedrine. Acceptable identification is required from the purchaser and additional records need to be made.

Over-the-counter medicines

Pharmacy Medicines and Pharmacist Only Medicines

Look up the definitions of Schedule 2 and Schedule 3 medicines in the SUSMP

Look up the endorsements for pharmacists and pharmacy assistants in the HDPR for poisons

Who can sell S2 and S3 medicines?

Pharmacists:
dispense or sell S2, S3 and S7 poisons
Pharmacy trainee:
sell S2 or S7 poison at a dispensary under a pharmacist’s direction
sell a S3 poison at a dispensary under a pharmacist’s direction and personal supervision
Pharmacy assistants:
a competent employee is authorised to sell S2 or S7 at a dispensary

You may need to look up some of these terms (Appendix 9 and s3–8).

Can a third year pharmacy student sell a S3 poison while the pharmacist is out-the-back dispensing a dose-administration aid?

Storage of S2 and S3 medicines

Can paracetamol be stored in the front shop of a pharmacy?

Look up s284. To answer the question you will also need to look up paracetamol in the SUSMP.

Contrast s284 with s211 and s118

Dispensing or selling S2 and S3 medicines

A pharmacist must adopt a quality standard

Like restricted drugs and controlled drugs, pharmacists can’t sell or dispense S2 or S3 medicines unless they have and comply with a quality standard (s273A)

What is the difference between “dispensing” and “selling” a S2 or S3 medicine?

Sale of S3 poisons (s277)

s277 provides the regulations for pharmacists selling S3 poisons: “Pharmacist Only Medicines”.

Read s277

Do pharmacists need to label S3 poisons for sale?

What do pharmacists need to ensure before selling S3 poisons? s277(1)(a)(i) and s277(1)(b)(i)

What information must pharmacists provide customers about S3 poisons? s277(2)

Pseudoephedrine

Therapeutic use

You will have noticed specific regulations for pseudoephedrine.

Pseudoephedrine is a decongestant medication that is primarily taken orally. It is relatively effective at reducing nasal congestion for someone who has a cold, and was readily accessible in many over-the-counter “cough and cold” remedies.

Pseudoephedrine diversion

Diversion of pseudoephedrine to illegal laboratories where it is used as a precursor for amphetamines has been a significant problem in Queensland.

10–15 years ago it was common to have groups of people going from pharmacy to pharmacy to buy as many pseudoephedrine-containing products as possible.

This has led to much tighter regulation of pseudoephedrine sales.

Pseudoephedrine regulations

Scheduling was changed in 2006 to limit pack-sizes and restrict availability without involvement of a health professional.

Strategies to reduce pseudoephedrine diversion:

Project Stop

Project Stop is the online database that pharmacists enter details of pseudoephedrine sales into.

Entering details into Project Stop satisfies s285A(2).

Berbatis et al. 2009 showed a reduced number of clandestine laboratories were seized in Queensland following the initiation of Project Stop. Presumably fewer could open without access to pseudoephedrine as a precursor.

Summary

This completes the module. Test your knowledge on this section of the module in the associated quiz.