The General Pharmaceutical Council (GPhC) sets standards for registered pharmacies. You, and your staff, must know the standards and ensure you achieve, and maintain, regulatory compliance or face the prospect of sanctions. GPhC set standards for pharmacy professionals and registered pharmacies in Great Britain.
The GPhC makes clear that everyone in the pharmacy team should be familiar with its standards for registered pharmacies, but ultimately the responsibility for meeting the standards lies with the pharmacy owner.
As well as meeting our standards, pharmacy owners must:
- make sure they comply with all legal requirements including those covering medicines legislation, health and safety, employment, data protection and equalities legislation.
- make sure that all staff, including non-pharmacists, involved in the management of pharmacy services are familiar with the standards and understand the importance of their being met.
- pharmacists and pharmacy technicians must understand that they have a professional responsibility to raise concerns if they believe the standards are not being met.
Do you know what the GPhC standards are?
The GPhC’s standards are grouped under five principles. The principles are referred to as “the backbone” of the GPhC’s regulatory approach and are all equally important.
Principle 1: The governance arrangements safeguard the health, safety and wellbeing of patients and the public.
Principle 2: Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public.
Principle 3: The environment and condition of the premises from which pharmacy services are provided, and any associated premises, safeguard the health, safety and wellbeing of patients and the public.
Principle 4: The way in which pharmacy services, including the management of medicines and medical devices, are delivered safeguards the health, safety and wellbeing of patients and the public.
Principle 5: The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public.
GPhC registered pharmacies, enforcement and fitness to practise
The GPhC have statutory powers to act “to protect the public and to uphold public confidence in pharmacy” if it receives concerns about a registered pharmacy. These powers include enforcement options and enforcement powers:
- Improvement action plans – Generally the first enforcement option and where there is no immediate risk to the public or patients. Improvement action plans require pharmacy owners to develop an improvement plan, setting out what they will do, within a set time, to put right the issues and meet the standards.
- Conditions on registration – Registered pharmacies can have conditions attached to their registration when this is necessary for the purpose of “securing the safe and effective practice of pharmacy at those premises”. Unless there is deemed to be an immediate public safety risk, pharmacy owners will have “reasonable notice” in writing of the condition(s) to be imposed and failure to comply with conditions can lead to an improvement notice.
- Improvement notices – Where the GPhC have reasonable grounds for believing there is a failure to meet standards for registered pharmacies, or a failure to meet conditions relating to the standards, they can serve an improvement notice. Pharmacy owners are responsible for making sure that the improvement work is carried out within the timeframe set out in the improvement notice (at least 28 days).
Enforcement and Fitness to Practise
If a pharmacy owner fails to comply with the improvement notice, the matter must be referred to the GPhC’s Fitness to Practise Committee for consideration as a “disqualification case”.
The GPhC’s Fitness to Practise Committee can disqualify a pharmacy owner for failing to meet the standards and remove their premises from the register. The fitness to practise committee can also suspend a pharmacy premises in lieu of a full hearing, prior to a disqualification decision or removal direction taking effect.
Disqualification and removal directions may be given for a limited period, meaning that premises entries will be restored at the end of that period.
Right of Appeal
Certain GPhC enforcement actions are appealable. Pharmacy owners can appeal the following actions:
- Improvement notices to the Magistrates’ court, or in Scotland to the sheriff. An appeal must be brought within 28 days beginning with the date on which the improvement notice was served. The Court may suspend an improvement notice pending the determination or abandonment of the appeal. On appeal against an improvement notice, the court may either cancel the notice or confirm it, with or without change.
- Disqualification, removal directions & interim suspensions to the High Court (or the Court of Session in Scotland) within three months beginning with the date on which the direction is given.
In all other cases, judicial review proceedings might apply depending on the individual circumstances.
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Disclaimer: This article is for guidance purposes only. Kings View Chambers accepts no responsibility or liability whatsoever for any action taken, or not taken, in relation to this article. You should seek the appropriate legal advice having regard to your own particular circumstances.
