Risk-based regulation of healthcare professionals: What are the implications for pharmacists?

Abstract

One of the key drivers of regulatory reform is minimising the risks associated with healthcare. In order to achieve this, there is a need for the regulatory bodies to have a clear understanding of what comprises risk in the professions under their remit. The current paper examines ways in which risk could be conceptualised, assessed and managed in one of these professions: pharmacy. The authors review studies in healthcare management, safety science and human factors, and consider a range of views about the nature of risk and its relationship to pharmacy practice. This leads to an exploration of the implications for risk-based regulation (for example, revalidation), and of issues to be addressed in further work in thisarea.

Keywords:

• pharmacy
• human factors
• risk
• regulation
• revalidation

Notes

1. ‘Hazard’ is used here to refer to a specific agent that potentially has an adverse effect within a work system, and hence can be considered a source of risk (Hale and Glendon 1987).

2. A case in point is the UK Council for Healthcare Regulatory Excellence's (Council for Healthcare Regulatory Excellence 2010) recommendation that students and providers of healthcare professional education should, in future, be prepared to share fitness to practice sanctions with the respective regulator. The CHRE cites both anecdotal evidence and studies such as Papadakis et al. (2005, 2008) in support of this recommendation. However, it notes concerns by those affected that such a policy might, in terms of perceived intrusiveness, be felt to be disproportionate to the benefit gained for public protection.

3. Examples of the latter include medicine use reviews and advanced/specialist practice in the United Kingdom, medication therapy management services in the United States, and pharmaceutical opinions in Canada.