Poisons Regulation and Pharmacy Practice: Overview

Semester 1, 2017

Background

Why regulate?

The provision of healthcare is tightly regulated. You (probably) want it that way—certainly society wants it that way. The principle purpose of regulation (healthcare or otherwise) is to keep the public safe.

Pharmacy Practice and regulation

Practicing pharmacy well means practicing in accordance with the law.

Practising outside of the law puts the public at risk.

If that is not a good enough reason; practising outside the law puts you at risk.

Risk of civil litigation

Risk of professional censure: unprofessional conduct/professional misconduct (perhaps leading to removal of registration).

Risk of prosecution in the courts for breaches of the HDPR

Pharmacy Law

Quite a lot of legislation is relevant to pharmacy practice.

Download and save a copy of each of these pieces of legislation (you will be working closely with them). These documents are also available via Blackboard.

Aim

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’ll focus on the first objective

Understand the purpose and contents of the HDPR in the context of pharmacy practice

We will start with the broader context.

Key concepts

These are the key concepts you should take away from this section of the module:

  1. The HDPR provides the regulations for prescribing, dispensing and other forms of medication supply in Queensland.
  2. The SUSMP provides the scheduling for all medicines available in Australia. Key schedules for pharmacy: S2, S3, S4 and S8. The higher the schedule the tighter the HDPR regulations for prescribing and dispensing the medicine.
  3. There are additional important influences and guidance on dispensing, including: professional standards, key pharmacy resources and the Pharmaceutical Benefits Scheme

HDPR in context

The dispensing process

The HDPR provides (among other things) the regulations for prescribing and dispensing in Queensland.

Here’s a schematic of the dispensing process:

  1. What schedule is the medicine?
  2. Is the prescription legal?
  3. Is the prescription therapeutically appropriate?
  4. Dispense the prescription
  5. Is the label legally and professionally appropriate?
  6. Consult with the patient

Step 1: Scheduling (SUSMP)

Key Schedules

Different terminology used for drug schedules. The SUSMP has schedule 1–9. S2–4 and S8 are the schedules that you most frequently come across in pharmacy.
SUSMP HDPR Alternatives Examples
S2,S3 Poisons Over-the-counter drugs Paracetamol
S4 Restricted drug Prescription drug Antibiotics
S8 Controlled drug Dangerous drug Opioids

Steps 2, 4 and 5: HDPR

The HDPR provides the regulations for judging whether the prescription is legal and dispensing the prescription with a legal label. It also legislates which professions are permitted to prescribe, dispense and supply medicines. This is refered to in the HDPR as an endorsement.

We will work through the key sections of the HDPR shortly.

First we discuss some of the additional guidance available for (and influences on) the dispensing process: key reference texts, professional standards and the Pharmaceutical Benefit Scheme.

Step 3: Key pharmacy references

Judging whether a prescription is therapeutically appropriate for the individual in front of you is arguably the most difficult (and important) step.

A common (and sometimes difficult) judgement you need to make is whether the prescribed dose is appropriate for the patient.

A number of resources help inform this judgement:

  1. Australian Medicines Handbook
  2. Australian Pharmaceutical Formulary
  3. MIMS Online
  4. Therapeutic Guidelines

Further information is covered in the Posology Module on Blackboard.

Professional Standards

“Professional standards” are standards of practice that have been developed by the profession. The standards cover dispensing, counselling, and most common activities of pharmacists.

Key documents include:

What professional standards do

Professional standards describe how pharmacists should practice.

The competency standards describe the knowledge and skills required to practice pharmacy

The professional practice standards describe how pharmacists should provide good care; e.g. the systems and procedures they should put in place to ensure accurate dispensing, and the level of information they should provide patients when prescribed a medicine.

Quality standards

Quality standards are very specific professional standards for performing certain tasks, such as dispensing.

The best known quality standards in pharmacy are those provided by the Quality Care Pharmacy Program

Adopting a quality standard for dispensing is a stipulated requirement in the HDPR.

Additional professional guidance

Pharmaceutical Benefits Scheme

The Pharmaceutical Benefits Scheme is the mechanism by which the Australian Government subsidises the costs of necessary medicines for the Australian public.

Many of the drugs dispensed in community pharmacies are subsidised through the Pharmaceutical Benefits Scheme (otherwise known as the “PBS”).

The PBS places requirements on prescriptions—if the prescription does not meet these requirements the prescription can’t be subsidised under the PBS.

It is important to distinguish between the legal requirements placed on prescriptions by the HDPR and PBS requirements.

If the prescription is legal, but does not meet the PBS requirements, you can dispense the prescription privately. That is, the patient pays the full price as opposed to the subsidised PBS price.

Summary

A schematic summary of how these sources of guidance (regulatory, professional and others) can be found here (and on Blackboard).

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