The whole pharmacy team needs to be involved in preparations for GPhC inspection. What can be done to make sure everything is in place?

The regulation of healthcare professionals has been increasingly in the spotlight in recent years. The public attention that was focused on the Shipman and Bristol babies cases drove changes in the regulation of individual practitioners. This was ultimately the driver for the split of the regulatory and representative functions of the RPSGB and the introduction of the GPhC.

In more recent times the regulation of premises has been brought into much sharper focus. The Mid Staffordshire Hospital scandal, and the Francis report that followed it, demonstrated the need for a more structured approach to the regulation of premises from where healthcare services are provided. The Care Quality Commission (CQC) – the body regulating hospitals, care homes, GP practices and medical clinics – is regularly in the spotlight.

The GPhC is in the unusual position of regulating both individual registrants and the premises. It responded effectively to the changes in the regulation of individual professionals. The recent changes in inspection have been the GPhC’s response to the need to have a more robust process for the regulation of premises.

The new inspection system

The previous model of inspection involved GPhC inspectors visiting a pharmacy and looking at a snapshot of practice. The evidence that this practice was objective and reproducible was limited and these are key issues for the governance of regulation.

The new inspection system gives a framework that allows objective decision-making and for clear feedback to be given to pharmacists and their teams. It is designed to give a more longitudinal view by looking at process and to understand how this is implemented by the whole pharmacy team.

It shows the evidence upon which decisions are being made. Importantly, it provides a way of quality assuring the process to demonstrate that the system is robust. The inspection process is currently grading pharmacies as poor, satisfactory, good or excellent, although this system is under review.

Pharmacies graded as poor or satisfactory are required to complete an improvement action plan. With this system, it is hoped that standards are incrementally raised over a number of years.

Show me, tell me

The inspections use a ‘show me, tell me’ approach. Written evidence should be available, such as standard operating procedures (SOPs) or risk assessments, which the inspector can review. Members of the pharmacy team should be able to answer questions about the processes in the pharmacy to demonstrate how the written policy and procedures are implemented and lived.

Inspectors will not expect every member of the team to be able to deal with every situation, but would expect individuals to know what could be reasonably expected of someone in their role. For example, a team member who works in the retail area of a pharmacy might be expected to know that if a patient complains about a dispensing error they should refer them to the pharmacist and that the potential error will be investigated. A dispenser or technician might be expected to understand and explain in more detail about what the investigation would involve.

It is not enough to have an SOP to define how something should be done. An inspector will expect a pharmacist or superintendent to provide evidence that the pharmacy team knows the SOPs that are used in the pharmacy and that these reflect what actually happens in practice.

By triangulating evidence from written materials, discussion of scenarios with the pharmacy team and personal observation, inspectors are able to deliver more robust and objective decisions.