The PSI would like to provide pharmacy professionals and pharmacies with an overview of the position paper, PSI position paper on the need for reform of the Pharmacy Act 2007, which is published at psi.ie > Publications > Advancing reform of the Pharmacy Act 2007.
The paper sets out the PSI’s position on the need for reform of the Act and the reasons why significant legislative reform is needed. As well as outlining the Act’s key challenges and weaknesses, the paper highlights some examples of regulatory tools and practices used by other regulators, which were identified through research.
It is widely recognised that regulatory systems, in order to be effective, must be regularly reviewed to ensure they continue to meet their intended policy objectives.
Since the commencement of the Act in 2007, which established the PSI as the pharmacy regulator and introduced many of the fundamentals of regulation in Ireland, pharmacy practice has expanded and diversified. Furthermore, during this time, PSI has experienced a number of challenges in using the Act in practice.
While it is ultimately the remit of the Department to reform the Act, there is also a growing recognition of the responsibility of regulators, such as the PSI, to be good regulatory stewards of their regulatory systems. PSI therefore has a responsibility to ensure that the Act and regulations remain fit for purpose in a changing regulatory and healthcare environment and that they can support regulation now and into the future and ensure the safety of patients and the public.
PSI has therefore been engaging with the Department on advancing reform of the Act in the public interest since 2018. As part of this engagement, the PSI committed to developing the PSI position paper on the need for reform.
The position paper describes the challenges and weaknesses identified in the Act across three areas:
In the position paper, we identify several significant challenges in the Act in the area of the regulation of pharmacies and describe how these limit our effectiveness in ensuring that patients receive safe, high-quality pharmacy services.
The Act and its regulations focus predominately on the safe management of medicines when they should be centred on the patient and the safety and quality of the services patients receive, including the safe management of medicines. This focus on medicines reflected pharmacy practice at the time the Act was drafted but has not kept pace with the expansion and diversification of pharmacy services. We outline how a reformed framework based on revised, broader regulations and supported by outcomes-focused healthcare regulatory standards would enable PSI to monitor broader aspects of the provision of pharmacy services.
We also examine our enforcement powers under the Act that require the PSI to use the same fitness to practise system for pharmacies which is intended to regulate the competence and conduct of individual pharmacists. The paper describes how findings have been made against a pharmacy only twice in the past ten years through the fitness to practise system. We outline how it is essential for effective regulation of pharmacies that PSI can take a range of flexible enforcement actions proportionate to the risk posed to patient safety and the public.
PSI also believes that the governance and accountability of pharmacies need to be strengthened. The paper examines overlapping accountability and responsibilities across governance roles in the Act. It outlines how our current legislation does not require the same level of checks and balances for an individual to take on a governance role in a pharmacy as those required by other regulators for similar governance roles.
We also highlight that there is currently no mandatory national system to report errors or incidents in pharmacies – a significant deficit that presents patient safety risks. The Act and regulations also place very limited statutory obligations on pharmacies to provide solicited information (information a service provider is required to provide under statutory obligations) to the PSI.
The paper describes a number of challenges we have experienced in operating the fitness to practise system for pharmacy professionals. We describe how the fitness to practise system is a long, inflexible process with duplication of decision-making and unnecessary complexity. We outline how from the initial stage when a complaint is made to the end of the sanctioning process (where appropriate), the fitness to practise system can take up to two to three years.
Lengthy and complex fitness to practise procedures present many risks to patient safety, including the potential to deter the public, other healthcare professionals or employers from making complaints to the regulator.
The paper examines a number of aspects of the fitness to practise process, including the interim suspension process, the limited set of tools under the Act to triage or investigate complaints at screening stage and the lack of provisions under the legislation to take an alternative action such as issuing advice or warning letters to the registrant who is the subject of a complaint.
The paper also highlights our concerns that the current process for managing health cases is overly adversarial and could present a risk to patient safety as it may discourage pharmacists from seeking support or an employer or colleague from raising a concern to the regulator about the health of a registered pharmacist.
Governance structures and role of Council
The final area in which we identify weaknesses in the Act is in the area of PSI governance. We describe how, despite many strengths in the governance structure of the PSI, the Act presents a number of challenges for the PSI Council in carrying out its functions, including challenges relating to the size and structure of the PSI Council and the role of Council in the sanctioning stage of the fitness to practise process, which creates duplication of decision-making and limits Council’s availability to oversee policy, strategy, and governance.
The focus to date has been on problem identification and analysis of the challenges and weaknesses of the Act. The next stages in advancing reform of the Act will involve the commissioning of in-depth evidence reviews/expert reviews to inform the development of evidence-based policy proposals for reform of the Act.
It was agreed with the Department of Health in March of this year that PSI would begin by commissioning an in-depth evidence review in the area of the regulation of pharmacies in the first instance.
PSI will also establish an advisory group comprising expertise from a number of key stakeholders as part of the project. We also envisage that further stages of the project would involve significant public consultation.
We look forward to sharing further updates on our progress in this area.
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