For every pharmacy in the UK, being prepared for a General Pharmaceutical Council (GPhC) inspection is essential for patient safety and regulatory compliance. The GPhC’s inspection model has evolved to be more dynamic and focused, putting the onus on pharmacy owners and superintendent pharmacists to ensure their teams are inspection-ready.
Let’s break down what UK pharmacies need to know about these assessments.
GPhC pharmacy inspection types
The GPhC employs a variety of inspection types:
- Routine inspections: These are regularly conducted to assess ongoing compliance. They can be either:
- Focused inspections: Shorter and more targeted, these concentrate on key patient safety standards (18 core standards: numbers 1.1, 1.2, 1.3, 1.5, 1.6, 1.7, 1.8, 2.1, 2.2, 2.3, 3.1, 3.2, 3.4, 4.1, 4.2, 4.3, 4.4, 5.1). This includes the most frequently unmet standards and those critically impacting patient safety. They are efficient, allowing for more frequent inspections and can be used for re-inspections following previous non-compliance. Inspectors retain the flexibility to switch to a full inspection if needed.
- Full inspections: These are in-depth assessments, encompassing all the standards for registered pharmacies. They are always carried out for pharmacies being inspected for the first time or when an inspector determines a more comprehensive review is necessary.
- Intelligence-led inspections: Prompted by information received from various sources, including the public and other regulators, these inspections enable the GPhC to address specific risks or concerns rapidly.
- Themed reviews: These inspections focus on specific areas of pharmacy practice or emerging trends, allowing the GPhC to gather insights and provide guidance on particular aspects of care.
Most inspections are unannounced. Pharmacies can expect a visit every 3-5 years, with more frequent inspections if intelligence warrants it. This means that continuous preparedness, rather than last-minute cramming, is crucial.
Transparency is also a growing focus. Examples of notable practice are shared in the knowledge hub, a valuable resource for learning and improvement across the sector.
GPhC standards for pharmacies
The bedrock of any inspection is the GPhC’s set of standards. These are detailed on their website and cover five core principles, all equally important:
- Governance arrangements safeguard the health, safety and wellbeing of patients and the public. This covers everything from Standard Operating Procedures (SOPs) and complaint procedures to maintaining accurate records and protecting patient confidentiality.
- Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public. This focuses on adequate staffing, ongoing training, a culture of openness and clear whistleblowing policies.
- The environment and condition of the premises safeguard the health, safety and wellbeing of patients and the public. This includes maintaining clean, secure and compliant premises that prioritise patient privacy and safety.
- The way in which pharmacy services are delivered safeguards the health, safety and wellbeing of patients and the public. This encompasses clearly displayed services, promoting healthy lifestyles, proper stock management and adherence to new regulations.
- The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public. This covers the maintenance, calibration and suitability of all equipment, including IT systems for data protection.
How to prepare your pharmacy’s team for a GPhC inspection
Successful inspections hinge on a well-prepared and confident team. Here’s how to foster that readiness:
- Initial training isn’t enough. Ongoing development, including scenario-based questioning and role-playing, will help staff feel comfortable and knowledgeable when speaking with an inspector.
- Ensure all staff are familiar with and adhere to current SOPs. These are your documented proof of how standards are met.
- Proactively identify and address any gaps before an official inspection. This also builds team familiarity with the inspection process.
- Discuss the inspection process with your entire team. Inform them about what to expect when an inspector arrives, the importance of politeness and openness and how to effectively promote the pharmacy’s services and the team’s capabilities.
- Have a comprehensive locum pack ready with all essential pharmacy information to ensure continuity of care and compliance, even during staff absences.
- Ensure all staff are proficient in locating essential operational documents, including but not limited to: complaints logs, cleaning schedules, waste collection details, equipment service records, fire safety and health & safety audits (including risk assessments and COSHH), incident/near miss reports, safeguarding guidance, IG toolkit certificates, training files, the whistleblowing policy and data protection policies in line with GDPR.
During a GPhC pharmacy inspection: what to expect
When the inspector arrives, the Responsible Pharmacist (RP) should welcome them, ascertain their plan for the inspection and facilitate their access to information and staff.
During an inspection, GPhC inspectors engage with the entire pharmacy team, not just the owner or Responsible Pharmacist. They gather evidence through various methods:
- Reviewing documentation, including written policies, procedures and records.
- Observing how staff interact with patients and carry out their duties.
- Asking questions and posing scenarios, which helps assess the team’s understanding and application of procedures.
- Testing systems and processes to ensure their effectiveness.
To determine if a pharmacy meets all standards, inspectors will gather evidence through a combination of contextual questioning and a ‘show and tell’ methodology.
Encourage your team to provide as much detail as possible, even for things the inspector might not explicitly ask for. Also, it’s key to clearly communicate the range of services you offer and the positive impact your team has on the community. Demonstrate your processes and show evidence of compliance.
GPhC inspection outcomes and next steps
At the end of an inspection, the RP will receive feedback. The outcome will be either ‘standards met’ or ‘standards not all met.’ Pharmacies not meeting all standards will need to complete an Improvement Action Plan (IAP), outlining how they will address the identified areas. These IAPs are now publicly published alongside the inspection report.
Each of the five principles will also receive one of four findings: excellent practice, good practice, standards met, or standards not all met.
It’s crucial for owners and superintendent pharmacists to act swiftly on IAPs, especially where patient safety is concerned. The GPhC expects notification of actions within 5 days and sets deadlines (10, 20 or 60 working days) for completion. A follow-up inspection will then be scheduled, usually within six months, to verify that improvements have been sustained.
GPhC inspection report transparency
GPhC inspection reports are published online. Pharmacy owners have an opportunity to review the report for factual accuracy before finalisation. If you believe the overall outcome of an inspection doesn’t reflect the evidence, you can request a formal review within 5 working days of receiving the final report.
The GPhC’s ultimate goal is to encourage compliance, but they do have enforcement options if standards are not met or patient safety is at serious risk.
GPhC inspection fines and consequences
The GPhC itself, as a regulator, primarily uses registration sanctions (like imposing conditions on a pharmacy’s registration, or in serious cases, suspending or removing the pharmacy from the register) for breaches of its standards.
However, the Pharmacy Order 2010 includes specific offenses in its Article 14, and proceedings may be commenced at any time within a 6-month period.
For these offenses under the Pharmacy Order 2010, the penalty can be an unlimited fine. For many summary offenses in the UK, the maximum fine was a set amount (e.g., £5,000). However, since 12 March 2015, the cap on fines for most summary offenses heard in a magistrates’ court has been lifted. This means that a magistrates’ court can impose an unlimited fine for such offenses, although the fine must still be proportionate to the offense and the offender’s means.
For more serious offenses, or those that could be charged under broader criminal law (e.g., the Medicines Act 1968, or general criminal law like manslaughter in extreme cases of dispensing errors leading to death), the penalties can be much severe, including significant fines and/or imprisonment. For example, the Bribery Act 2010 can lead to custodial sentences of up to ten years and a fine for individuals found guilty of bribery.
On the other hand, the GPhC can pursue convictions for specific offenses under the Pharmacy Order 2010 (e.g., intentionally obstructing an inspector exercising functions, failing to assist an inspector, providing false information, or failing to produce a document or record when required to do so). For these offenses, the penalty can be up to £1,000.
Conclusion
Here are some final hints for success: it is crucial to communicate any absences, such as holidays, to the GPhC. Always prioritise patient safety, immediately addressing any concerns in your action plans. Furthermore, ensure all actions within your Improvement Action Plan (IAP) are assigned clear deadlines and set reminders to maintain accountability.
By understanding the GPhC’s inspection framework, preparing your team and maintaining a proactive approach to upholding standards, your pharmacy will be well-equipped to confidently navigate inspections.