Regulatory Risk Statement

Regulatory Risk Statement CoverRegulatory bodies, such as the PSI, have a duty to recognise and respond appropriately to risks and potential harms that relate to our area of accountability, with the purpose of protecting the health and safety of patients and the public. To achieve this the PSI believes in maintaining a clear understanding of the current and emerging risks that may arise in the practice of the pharmacy profession and the delivery of pharmacy services, consistent with our regulatory responsibility.

The PSI has developed a Statement on Regulatory Risk, which sets out how we define, identify, analyse and respond to risk across all our areas of responsibility. By implementing this strategic risk-based approach in our regulation of pharmacists and pharmacies, our work aims to prevent harm to patients by making pharmacy a safer environment.

The Regulatory Risk Statement supports our mission, vision and values and outlines how we will ensure:

  • we have everything in place to address risks arising within our field of regulation,
  • a reduced risk of harm to the public by the effective mitigation of regulatory risk, and
  • it is fulfilled in a way which will meet the high standards expected of public bodies.

The Statement covers an initial three-year period (2019-2021), and during this time the Statement will evolve in line with any developments within the pharmacy domain.

The PSI is committed to assuring public trust by evolving how we meet our responsibilities and exploring new ways of regulating that are proportionate, effective and efficient.