Dispensing and labelling medicines

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 continue our focus on Objective 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

In this module we focus on dispensing and labelling requirements

Key concepts

  1. Dispensing is much more than labelling a medicine.
  2. Pharmacists must dispense according to a quality standard. Therapeutic review is a required part of that standard.
  3. The requirements on labels for controlled drugs, restricted drugs and S3 poisons are similar.
  4. To produce appropriate labels you need to know both what is explicitly stated in the HDPR and what is professionally required (e.g. the need for both drug name and brand name)

Dispensing

The process of dispensing

A pharmacist must not dispense (or sell) a controlled drug, restricted drug or S2/S3 poison unless they

  1. Have prepared or adopted a quality standard, and
  2. Comply with that standard in dispensing (or selling) the drug.

See s81A, s192A

Read the interpretation of “quality standard” given in s4A

Quality standards

The HDPR doesn’t stipulate what the quality standard needs to be, but does state that it needs to be consistent with professionally recognised standards.

Key documents/resources include

Responsibility

In dispensing a medicine, pharmacists are responsible for ensuring that the medicine is appropriate and safe

Read s4A(4)

This is critical: Dispensing is not just about correctly following a prescription.

From the Pharmacy Board’s Guidelines on dispensing:

In dispensing a prescription, a pharmacist has to exercise an independent judgement to ensure the medicine is safe and appropriate for the patient.

Continued Dispensing and Emergency Supply

There are a number of provisions for pharmacists to dispense medicines without a written or oral prescription from a prescriber.

The two main provisions within the HDPR are continued dispensing and emergency supply.

Emergency supply is relatively straightforward, see s194

Continued Dispensing refers to a Determination under the National Health Act. The National Health Act provides the legislative framework for the prescription, supply and funding of the Pharmaceutical Benefits Scheme.

While the Determination for Continued Dispensing was made in 2012, it was not legal in Queensland until 2016 (see the ‘Note’ in HDPR s171(f)).

For futher information on Continued Dispensing, see

Labelling

HDPR labelling requirements

The explicit requirements are provided in s85 (controlled drugs), s198 (restricted drugs) and s276, S277 (S2, S3 poisons)

There is a lot of overlap in the HDPR labelling requirements. s85 and s198 are not identical, but are close.

Like the requirements of a prescription, pharmacists tend to know these requirements by heart. You need to know the HDPR labelling requirements.

Additional labelling requirements

There are some items that are professionally required to be on a label for a dispensed medicine that are not stipulated in the HDPR.

Two important examples:

The dose form (e.g. “tablet”, “capsule”, “metered dose inhaler”, etc) (check its absence in 85(3)(e))

Inclusion of both the drug name and the brand name (see s85(4) for what is stipulated)

As a contrast, read section 7 of the Board’s “Guidelines for dispensing of medicines”.

Implicit labelling requirements

Exercise: think through why including the drug’s dose form and both brand and drug name on a label are professionally required.

While these items are not in stipulated in the HDPR, they are both stipulated in the Pharmacy Board’s Guidelines for dispensing medicines.

The HDPR does stipulate the need for an adequate quality standard and for that quality standard to confirm to Pharmacy Board requirements.

Thus the inclusion of dose form and both brand and drug name are implicitly required by the HDPR

Summary

See “information on labelling” via Blackboard for guidance (see “Dispensing and Counselling Resources).

Do the quiz!