Inspections are based on five principles that drive standards to safeguard the health, safety and wellbeing of patients and the public. These principles are:

• Governance arrangements in the pharmacy
• Staff being empowered and competent
• Managing the environment and condition of the premises from which pharmacy services are provided and any associated premises
• Delivering pharmacy services in a way that is both safe and makes them accessible to all members of the community €“ this includes having appropriate arrangements in place for obtaining, storing, handling, using and disposing of medicinal products and medical devices
• Use of safe and suitable equipment and facilities when providing pharmacy services.

Pharmacies should be operating within these principles at all times and evidence should be collected to demonstrate this. This should be true under all circumstances and procedures should be robust and flexible enough to ensure the standards are met when operating with locums or when key team members are absent. If there is planned development work in the pharmacy, procedures should be adapted to ensure these principles are maintained.

The good news

The good news is that a pharmacy that is well run will already be doing the things that are expected by the GPhC. The community pharmacy team will understand their individual roles and follow procedures. They will already have much of the evidence required by the inspectors, although this might be in a disparate format and not coordinated or collated. What we need to do in the pharmacy is to put some process and structure around getting ready for inspection and this can be done in a number of steps:

• Familiarise yourself with the standards
• Collate or co-ordinate the evidence you already have
• Develop an action plan to meet identified gaps
• Brief or train the team.

Familiarise yourself with the standards

There are five principles on which the inspections are based. Underneath each of these principles there are a number of standards against which a pharmacy will be measured. Some of these standards will be quite simple to provide evidence for.

The standard that requires indemnity/insurance arrangements to be in place can be simply evidenced with an insurance certificate. Other standards are more detailed and do not lend themselves to the provision of simple evidence, but require a more comprehensive and disparate range of evidence.

While your pharmacy might run effectively and safely, failure to understand the standards will give the impression to the inspector that governance is not a priority in the pharmacy. Understanding the standards is also the first step to being able to collate good quality evidence that will support you through the inspection.

Collating the evidence you have

For each standard you will already have a range of evidence that will demonstrate how it is met. Spending some time identifying the evidence you already have will make the preparation for inspection seem a much less onerous task. If we take the first standard as an example, we can identify a range of evidence that will already be available in the pharmacy; risks associated with the provisions of pharmacy services are identified and managed.

There are a number of questions that we can ask to identify the evidence of benefit:

• Have you undertaken a risk assessment for the dispensing service you provide?
• Do you provide any pharmacy additional services? If you do, have you undertaken a risk assessment for each of those services?
• Are SOPs in place for the activities that are undertaken in the pharmacy? Have these SOPs been audited and do the procedures in the pharmacy match those written in the SOPs?
• Are the SOPs current? Have they been reviewed recently?
• Are individuals named on the SOPs and have those team members who have left the pharmacy been removed from the SOP?
• Do you have a robust system for recording and investigating dispensing incidents and near misses? Are all near misses recorded?
• Are there action plans that have been written in response to serious incidents or reviews of the near-miss log?
• Have you undertaken a proactive review of the dispensary to identify actions needed to avoid dispensing errors?
• Is there evidence of a date checking procedure?
• Is there a clear workflow and specific areas to separate different areas of work?
• Do you have specific places to store expired, returned or recalled stock? This range of evidence may already be available in the pharmacy in different places: the SOP file, the error log or the clinical governance folder.

These pieces of evidence do not need to be replicated in a separate file. Creating a reference source that signposts all the evidence will simplify the inspection process.