Interview with Bruce Battye Pharmaceutical Regulatory Unit

Bruce Battye, Director PRU

The Director the NSW Pharmaceutical Regulatory Unit, Bruce Battye discusses what his unit does and key prescribing issues doctors need to be aware of.


What is the Pharmaceutical Regulatory Unit (PRU) and what does it do?

The PRU is part of the Legal and Regulatory Services Branch of the NSW Ministry of Health. The Unit is responsible for the administration and enforcement of the Poisons and Therapeutic Goods Act 1966 and the Poisons and Therapeutic Goods Regulation 2008.

The Unit aims to minimise risk:

  • arising in the course of the prescription, manufacture, sale, supply, storage, handling, use and disposal of medicines and poisons, and
  • of medicines and poisons being diverted for unlawful purposes.

The PRU issues authorities to prescribe Schedule 8 drugs and a wide range of other authorities, including for the possession and supply of prohibited drugs for research purposes. The Unit licenses wholesale distributors of medicines, and undertakes inspections and investigations to ascertain compliance with the Poisons and Therapeutic Goods legislation.

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What type of prescribing creates the most trouble for doctors?

At the PRU inappropriate prescribing of Schedule 8 drugs is given priority. In NSW the abuse of prescription opioids - together with the associated risks of dependency and overdoses - is now a greater problem than illicit heroin.

The prescribing of high dose oxycodone, high dose fentanyl transdermal patches and injectable opioids are of particular concern. This concern is escalated with the concomitant prescribing of benzodiazepines, including alprazolam.

Prescribing of opioids to drug dependent patients without authority is a serious concern because of another prescriber who is already authorised to prescribe Schedule 8 opioids, the patient is at risk of an overdose.

It is very important to remember that an authority to prescribe Schedule 8 drugs issued by NSW Health is independent of an authority to prescribe under the Pharmaceutical Benefits Scheme (PBS) which is for the purpose of subsidising the costs of medicines to patients.

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Fentanyl has been in the media quite a lot lately. What should doctors be aware of when it comes to this drug?

The Unit is concerned that some doctors are prescribing fentanyl 100 mcg per hour transdermal patches to drug dependent patients without apparently recognising that the application of one 100mcg patch each 72 hours is the equivalent of an oral morphine daily dose equivalent of 300mg (oMEDD = 300mg).

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The injection of fentanyl extracted illegally from these patches is therefore of high risk, and may lead to overdose and death.

Fentanyl transdermal patches have high trafficking value. 

Doctors should be aware of the potential for trafficking of fentanyl transdermal patches when requested to prescribe these without adequate justification. This is especially the case with requests for private (non-PBS) prescriptions.

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All drugs should be prescribed within "recognised therapeutic standards" – what does this mean?

Whether we are considering Schedule 4 or Schedule 8 drugs, there will generally be no issue with recognised therapeutic standards when prescribing within the Therapeutic Goods Administration’s published approved indications and at recommended doses (according to the approved Product Information).

Some examples of prescribing outside of recognised therapeutic standards of concern to the PRU include prescribing phentermine as a stimulant to truck drivers, prescribing benzodiazepines long term for the purpose of maintaining a dependency, prescribing somatropin and anabolic androgenic steroids for bodybuilding, and prescribing of fentanyl 100microgram/hour transdermal patches at an application rate of more than one every 72 hours, or as private prescriptions for the supply of two, three or more packs at a time. 

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What should doctors take into account if they wish to prescribe off label medicines?

The evidence base should be considered for any prescribing off label medications that are not in accordance with the approved indications of evidence accepted by relevant specialists or their specialist professional colleges. Evidence could include: evidence recognised in clinical practice guidelines (such as Therapeutic Guidelines; evidence published in recognised peer-reviewed journals.

Doctors should also consider whether off label prescribing is acceptable to their indemnity insurers.

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And what about prescribing non-evidence-based drugs?

Outside a clinical trial framework, prescribing non-evidence-based drugs may precipitate a complaint of professional misconduct. Prescribing drugs without an acceptable evidence base should be regarded as experimental, where patient health and welfare may well be put at unacceptable risk.

An example is the prescribing of Melanotan II, prescribed as a pharmacy compounded medicine for the lifestyle purposes of sunless tanning, appetite suppression and sexual stimulation. 

The Therapeutic Goods Administration has stated that in the absence of any detailed risk analysis, there is no clinical and efficacy data related to Melanotan II, and the side effects and toxicity profile greatly outweigh any benefits of use.

For more information about the PRU go to:


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