The GPhC is unique among healthcare professional regulators in having an Inspectorate (who are appointed under Article 8 of the Pharmacy Order 2010). The inspectors are divided into three regional groups: the Northern, Central and South-Eastern region, each of which is managed by a Regional Lead Inspector.
Each inspector is responsible for between 500 and 600 registered pharmacy premises will complete in excess of 200 inspection visits per year.
The inspectors have two main roles:
Plus they also provide advice on compliance issues and liaise with other regulatory and enforcement agencies such as the police, Primary Care Trusts, the Healthcare Commission and the Medicines and Healthcare Products Regulatory Agency.
In ensuring that pharmacies comply with legal requirements and regulatory standards, inspectors will examine how the pharmacy operates and that it is safe and effective. If, during an inspection visit, an inspector finds that the pharmacy is not compliant with legal requirements or regulatory standards, then the inspector will advise the pharmacist and the superintendent (or owner) how they can secure compliance. The inspector may also initiate formal disciplinary proceedings if:
Every pharmacy will normally receive an inspection visit at least once every five years, or more frequently if an inspector believes more visits are necessary because, for example, the pharmacy provides services which are high risk, or because previous inspections or other information indicates that more frequent inspections are required.
Full details of what an inspector looks for during an inspection can be found on the GPhC website –
Following inspection, the pharmacy and pharmacy owner will get a copy of the controlled drug inspection report and, where appropriate, a report on other issues identified during the inspection visit that do not relate to the management and use of controlled drugs. The reports will identify areas of non-compliance and provide advice on how the pharmacy can improve and secure compliance.
By reason of Articles 10-12 of the Pharmacy Order 2010, an Inspector has the power to enter any registered pharmacy premises at any reasonable hour in order conduct an inspection and are not obliged to notify premises that they want to carry out an inspection. However, in the majority of cases they will send a pharmacy a notification of visit letter and a self-assessment form prior to their inspection.
In addition to regular inspections, the inspectors will also investigate complaints made against registered pharmacists, registered pharmacy technicians and pharmacy owners. Such complaints may have come from patients, the general public, other healthcare professionals, primary care organisations and other regulatory and enforcement authorities. Additionally, an investigation may result from an inspection if there has been persistent non-compliance with legal requirements or regulatory standards, or a significant risk to patient or public safety.
How the investigation is undertaken will depend upon the facts but may include:
The inspector may also formally interview pharmacists, their employees or owners of pharmacies in accordance with the provisions of the Police and Criminal Evidence Act 1984 and the relevant Codes of Practice made under that Act and may seize evidence as part of the investigation.
The time it takes to investigate depends on the gravity of the allegations and the complexity of the case but is usually completed within six months from receipt of the complaint.
Once it is concluded the GPhC will review the evidence and determine what action to take. All cases are assessed against threshold criteria which are used to decide whether to refer the case to the Investigating Committee.
