Abstract
BACKGROUND: Reforms to models of health and care regulation internationally have adapted to address the challenges associated with regulating healthcare professionals. Pharmacists in Ireland entered a new era of regulation with the enactment of the Pharmacy Act in 2007 which significantly updated the law regulating pharmacy in Ireland and expanded the regulatory scope considerably. An earlier study in 2017 examined the experiences of 20 community pharmacists of the Act. This follow-up study aimed to expand the scope of the original study to all community pharmacists in Ireland, to report their "lived experience" of the regulatory model introduced by the Act, assessing its impact on their professional practice using the principles of "better regulation". METHODS: Survey methodology was used to assess the perception of all community pharmacists registered with the Pharmaceutical Society of Ireland of the Act, as implemented, on their practice using an experimental design based on the seven principles of "Better Regulation". Descriptive statistics analyzed quantitative responses while answers from open-ended questions were analyzed using a combination of a modified framework analysis and a qualitative content analysis. RESULTS: Respondents agreed that the Act was necessary, although its implementation by the regulator was largely not viewed as fulfilling the remaining "Better Regulation" principles of being effective, proportional, consistent, agile, accountable and transparent. In particular, its proportionality was questioned. This resulted in pharmacists perceiving that their professional competency to act in the best interests of their patients was not appropriately acknowledged by the regulator, which in turn compromised their ability to provide optimal care for their patients. CONCLUSION: While healthcare professional regulation must primarily be concerned with public protection, it must also have regard to its impact on those delivering healthcare services. The findings highlight the challenge internationally of balancing rigidity and flexibility in professional health and care regulation, and the importance of a regulatory conversation occurring between those regulating and those regulated. This would serve to promote mutual learning and understanding to create a responsive approach to regulation, underpinned by mutual trust, effective risk assessment and adherence to the principles of "Better Regulation".