Navigating and understanding the HDPR

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 the second objective

Be able to navigate the HDPR

This is critical if you are going to achieve Objective 3: using the HDPR to assess legal prescriptions and to assess and create legal labels.

Key concepts

  1. The HDPR is organised according to the schedule of the medicine, e.g Chapter 2 Controlled Drugs, Chapter 3 Restricted Drugs, etc.
  2. Know key definitions provided by the HDPR (s4–8 and Appendix 9): endorsement, dispense, administer, supply, and regulated controlled and restricted drugs

Getting around the HDPR

Open the HDPR

Open a .pdf version of the HDPR on your computer.

Really. Do it now!

You need to be able to navigate and interpret the HDPR.

The best way to achieve this is to work with the document. For the rest of these slides I assume you have a .pdf version of the regulations open in an adjacent window.

Structure of HDPR

The best way to navigate the HDPR is via the table of contents, which is embedded in the .pdf meta-data.

Any good pdf reader should allow you to open the table of contents. What you have open should look like this:

HDPR with embedded table of contents on the right

HDPR with embedded table of contents on the right

Chapters, Parts, Sections, Subsections

Notice how the HDPR is divided. The first division is chapters, then parts, then the numbered sections (and subsections).

The picture on the previous slide shows Chapter 1, Part 2, Section 4A Quality Standards for dispensing certain drugs and selling certain poisons.

Notice that each section is numbered sequentially to the end of Chapter 5. This means we can name a section without providing the chapter/part; i.e. “s4A” uniquely names the section displayed on the previous slide.

After the chapters there are a number of appendices. Have a look at Appendix 4 and 9—we will refer to both.

Chapters

Chapters are (primarily) divided according to scheduling.

Understanding this is important. There is a lot of similarity in the regulations pertaining to controlled drugs and restricted drugs. What is the same is simply repeated in each chapter (look at s85 and s198). The differences can be subtle, but important.

Recall the dispensing process. First you determine the schedule of the prescribed medicine, and then you check the legality of the script. You need to know the schedule to know whether the script meets the legal requirements.

Key concepts for understanding the HDPR

Definitions and interpretation

A lot of distinctions are made in the HDPR. Some are defined externally, e.g. medicine schedules, others are defined within the HDPR.

Most of the key definitions can be found in Chapter 1, Part 2 Interpretation (i.e. s3–s8) or in Appendix 9 Dictionary.

It is important to refer to these definitions as you work with the HDPR—some of the distinctions are rather subtle.

Schedule of medicine

There is a good reason the HDPR is arranged according to the medicine’s schedule:

Many of the regulations provided in the HDPR are specific to the schedule of the drug; e.g. restricted drug (S4), controlled drug (S8) or poison (S2, S3).

Endorsement

The stipulation of who can do a particular action—i.e. prescribe, dispense, supply, administer—with each type of medicine (restricted drug, controlled drug, poison).

Notice that under each Chapter, there is a Part named Endorsements.

Where will you find which professions can prescribe restricted drugs?

Authorisations

Look at the endorsements that pharmacists have for restricted drugs (s171)

A number of activities are authorised by the HDPR: “obtain”, “dispense”, “sell”, “possess”, “destroy”, “administer”.

Notice that some of these activities are for all restricted drugs; e.g:

s171(1)(b): To the extent necessary to practise pharmacy, a pharmacist is authorised to dispense a restricted drug

While other activities are restricted to specific situations:

s171(3): During a declared public health emergency in relation to an infectious medical condition, a pharmacist is authorised to administer or supply oseltamivir or zanamirvir under a drug therapy protocol.

Clearly we need to understand the difference between what it is to dispense, supply and administer a medicine.

Prescribe, dispense, supply, administer

Each of these terms are defined in Appendix 9

Look them up!

The distinction between prescribe and dispense is relatively straightforward. More complicated is the distinction between dispense and supply.

Dispense v supply

Dispense
means sell on prescription
Supply
for a controlled or restricted drug or a poison, means give, or offer to give, a person 1 or more treatment doses of the drug or poison, to be taken by the person during a certain period.

This distinction is tricky. The definitions by themselves don’t quite get at it.

The key issue is who is endorsed to dispense and supply

Contrast s171(1)(b) with s175(2)(b)

Pharmacists are endorsed to dispense restricted drugs.

Registered Nurses are endorsed to supply restricted drugs in certain situations.

Dispense and supply v administer

Administer

for a controlled or restricted drug or a poison, means—

  1. give a person a single treatment dose of the drug or poison, to be taken by the person immediately; or
  2. cause an animal to take a single treatment dose of the drug or poison immediately.

Determine which of the following professions can administer controlled drugs: doctor, enrolled nurse, pharmacist.

“Regulated” drugs

The HDPR places additional regulations on a number of drugs. These are called “regulated controlled drugs”, “regulated restricted drugs” and “regulated poisons” respectively.

Two regulated restricted drugs commonly seen in community pharmacy are clomiphene (s187) and clozapine (s188)—look these medicines up in the AMH so you know what they do.

What are the additional requirements placed on (i) clomiphene and (ii) clozapine?

Warning: this is quite hard—there will be opportunity to discuss this further. A trail to follow: s187–8, s189(1)(a), and s190(2)(j).

Who is the Chief Executive?

Read s84(1)–(4)

After dispensing a controlled drug, you need to send an electronic notification to the chief executive.

It is also the chief executive who decides whether a person is suitable to hold and endorsement under the HDPR (see s15).

The “chief executive” is a placeholder for the top executive in the Department of Health in the Queensland Government.

Summary

You should now be able to get around the HDPR.

Use these skills. The nice thing about legislation is that it is written down—if you want to know what the law is find it and read it, and if necessary seek advice on how to interpret it.

Do the quiz! Then start the next section of the module.