The Pharmacy Act 2007 marked a significant overhaul in the regulation of pharmacy in Ireland, establishing the Pharmaceutical Society of Ireland (PSI) as the primary regulatory body and introducing a modern framework for the profession. For every Irish pharmacist, a thorough understanding of this Act is fundamental to safe and compliant practice.
This blog post will break down the key aspects of the Pharmacy Act 2007, highlighting what you need to know to navigate your professional responsibilities and ensure the highest standards of patient care.
The Pharmacy Act 2007 & the establishment of the PSI
At the heart of the Pharmacy Act 2007 is the Pharmaceutical Society of Ireland (PSI). The Act dissolved the ‘old Society’ and established a new, reformed PSI with a clear mandate to protect the public interest.
Key functions of the PSI under the Act include:
- Registration. The PSI is responsible for the registration of pharmacists, pharmaceutical assistants and retail pharmacy businesses. This includes setting criteria for qualifications, maintaining up-to-date registers and issuing certificates of registration.
- Education and training. The Act empowers the PSI to promote high standards of professional education, training and competence among pharmacists. This also extends to requirements for continuing education (CPD).
- Professional conduct. The PSI develops and enforces codes of conduct for pharmacists, ensuring ethical practice and patient safety.
- Inspections. The Act provides the PSI with powers of inspection for retail pharmacy businesses to ensure compliance with regulations and standards.
- Complaints and discipline (Fitness to practice). This is a crucial area. The Act established a fitness to practice process for both individual pharmacists and retail pharmacy businesses, outlining procedures for handling complaints, conducting inquiries and imposing disciplinary sanctions.
The Pharmacy Act 2007: Key responsibilities for pharmacists
The Act solidifies many of the responsibilities that have always been central to pharmacy practice, while also introducing new clarity and accountability. Here are some of the key areas where the Act directly impacts your day-to-day work:
- You must be appropriately registered with the PSI and ensure you remain ‘fit to practice.’ This involves not only initial registration but also adhering to continuing professional development (CPD) requirements and reporting any issues that might affect your ability to practice safely.
- The Act emphasises that the sale and supply of medicinal products must be under the personal and whole-time control of a registered pharmacist. For retail pharmacies, an experienced (minimum three years post-qualification) nominated pharmacist must be in personal and whole-time charge of each registered premises.
- The overarching principle of the Act is patient safety. Your practice must be directed towards maintaining and improving the health, well-being, care and safety of the patient. This includes:
- Providing a proper standard of practice and care.
- Using your professional skills and knowledge for the benefit of patients.
- Not purchasing or supplying products where safety or quality is doubted.
- Ensuring appropriate controls for managing the supply of medicinal products with potential for abuse or dependency.
- Respecting patient rights, including dignity, autonomy and confidentiality.
- Adhering to the PSI’s Code of Conduct for Pharmacists.
- You are responsible for complying with all relevant medicines legislation, including the Misuse of Drugs Acts and any directives from the Health Products Regulatory Authority (formerly the Irish Medicines Board).
- Maintaining accurate and detailed records of all transactions, particularly for controlled drugs and patient data, is a legal requirement. Compliance with GDPR is also essential.
- The Act specifically prohibits certain economic relationships between pharmacists/pharmacies and doctors to prevent conflicts of interest and ensure independent professional judgment. It also prohibits carrying on retail pharmacy businesses and medical practices together and improper recommendations.
The Pharmacy Act 2007: Impact and evolution
The Pharmacy Act 2007 was a transformative piece of legislation, modernising the regulatory landscape for pharmacy in Ireland. It introduced the formal regulation of retail pharmacy businesses for the first time, establishing minimum standards for premises. The Act also implemented an enhanced fitness to practice framework, providing a more robust mechanism to address concerns about professional conduct and competence while increasing public scrutiny. Ultimately, the legislation shifted the focus of the regulatory body firmly towards protecting the public interest, with increased non-pharmacist representation on the PSI Council.
While the core principles of the Act remain steadfast, it’s important to remember that legislation is not static. The Act has been subject to amendments and new regulations have been introduced since its commencement to reflect the evolving landscape of healthcare and pharmacy practice in Ireland. For example, subsequent regulations have clarified aspects of professional qualifications, fees and special measures, such as those seen during the COVID-19 pandemic.
The PSI regularly issues guidance and guidelines to help pharmacists understand their obligations under the Act and its associated regulations.
Why the PSI calls for Pharmacy Act 2007 reform
The Pharmaceutical Society of Ireland (PSI) has identified a need for urgent and fundamental reform of the Pharmacy Act 2007.
In its position paper, ‘PSI Position Paper on the Need for Reform of the Pharmacy Act 2007’, the PSI highlights several challenges and weaknesses in the current legislation. Key concerns include that the Act’s focus on regulating pharmacies is predominantly centered on the safe management of medicines, rather than the broader patient-centered services now provided.
The paper also points out limitations in enforcement powers for pharmacies and issues with their governance and accountability. Furthermore, the PSI’s fitness to practice system for pharmacy professionals is described as overly complex and lengthy, posing inherent risks to patients due to potential delays and a limited range of early regulatory tools.
Challenges also exist within the PSI Council’s governance structure, including its size, composition and involvement in sanctioning decisions. The PSI advocates for legislative reform to ensure the Act is ‘fit for purpose’ in regulating the expanding range of pharmacy services and to better support effective, patient-centered regulation now and into the future.
The Pharmacy Act 2007 provides the legal backbone for your profession in Ireland. It empowers the PSI to safeguard patient safety and uphold the integrity of pharmacy practice. As an Irish pharmacist, understanding its key provisions and your responsibilities under the Act is a commitment to delivering the highest standards of care to the public you serve. Make sure you regularly consult the official PSI website and the Irish Statute Book for the most up-to-date versions of the Act and any relevant amendments or rules. Your continued diligence is key to a respected pharmacy profession in Ireland.