This policy sets out the Pharmaceutical Regulatory Unit’s overall approach to compliance and enforcement that facilitates the effective achievement of the
A risk-based approach is applied to the regulatory functional decisions to enable resources to be targeted to the areas where they are most needed and that will prove to be the most effective.
Risk is measured in terms of the likelihood of an event occurring and the risk of harm to individuals and the community. More detail is provided in the risk matrix in Figure 1.
In Figure 1 multiple risk levels have been grouped and colour coded into extreme (red zone), high (amber zone), medium (yellow zone) and low (green zone) risk categories. Categorised risks are grouped according to likelihood and consequence. These groupings can provide measurable overall level of risk to determine the appropriate response to different levels of risks. It can also provide escalation points for risk management decisions, ensuring that risks are visible to, and managed at, the appropriate level within the Pharmaceutical Regulatory Unit.
An example of an event with low risk is the failure of a pharmacist to personally handle the sale of a Schedule 3 salbutamol asthma inhalant to a customer in breach of the Poisons and Therapeutic Goods Regulation 2008. The risks associated with such a breach is considered minor because the proper use of these inhalers is generally initiated under medical supervision and the great majority of supplies by pharmacists are repeat supplies where a pharmacist’s advice is not required.
On the other hand, the prescribing of high-dose Schedule 8 opioid drugs to drug dependent persons without authority in breach of Section 28 of the Poisons and Therapeutic Goods Act 1966 would be considered an event with high risk. This is because the likelihood of abuse/misuse is at a high level and the consequences of such misuse can be severe and potentially life threatening.
Actions taken by the Pharmaceutial Regulatory Unit in response to non-compliance will depend on the likely risk associated with the non-compliance.
Compliance policy risk matrix.
A graduated and proportionate approach is applied to the application of enforcement tools. A range of tools are available when taking action on a compliance matter, and in some circumstances multiple tools may be used at the same time.
The Poisons and Therapeutic Goods legislation provides for the authorisation of inspectors to exercise a variety of powers, including powers of entry, search and seizure of records and goods.
To facilitate compliance, guidance is provided to stakeholders, and interacts with stakeholders in a way that fosters understanding of the requirements and importance of compliance.
Advisory letters are issued to confirm verbal advice given by officers of the NSW Ministry of Health regarding insignificant or minor non-compliance with legislation.
Show cause letters are issued in accordance with statutory provisions of legislation when there is an intention to suspend or cancel a licence or authority.
Cautions or warning letters are issued to confirm verbal advice given regarding minor to moderate non-compliance with legislation, particularly where there is no previous history of non-compliance.
Restrictions or cancellation action is undertaken when there is evidence of major or extreme consequences to protect the health of individuals or the public generally.
Referrals to other co-regulatory agencies, such as health professional councils or the Health Care Complaints Commission, typically occur in circumstances where a health professional has engaged in professional misconduct. In some circumstances a matter may be referred to the police for investigation as a criminal matter.
Prosecution may be initiated for more serious breaches, but usually only when a more appropriate enforcement option is not available. Further information can be found in the NSW Ministry of Health document
PD 2014_021 Prosecution Policy and Guideline.
The Pharmaceutical Regulatory Unit may liaise and interact with numerous agencies with respect to compliance and enforcement matters. The agencies the Pharmaceutical Regulatory Unit most frequently engages with are: