Standards for registered pharmacies

The purpose of these standards is to create and maintain the right environment, both organisational and physical, for the safe and effective practice of pharmacy.

We recognise that for anyone operating a registered pharmacy, in the NHS or in the independent sector, there will always be competing demands. These may be professional, managerial, legal or commercial. However, medicines are not ordinary items of commerce. Along with the associated pharmacy services, medicines are fundamental healthcare services and this must be taken into account when applying these standards.

Responsibility for meeting the standards lies with the pharmacy owner. If the registered pharmacy is owned by a ‘body corporate’ (for example a company)the superintendent pharmacist also carries responsibility along with the company. Whoever is responsible, they need to take into account the nature of the pharmacy and the services provided and, most importantly, the needs of patients and members of the public. We also expect them to be familiar with all associated guidance, including our compliance guidance.

As well as meeting our standards, the pharmacy owner and  superintendent pharmacist must make sure they comply with all relevant legislation, regulatory standards and legal requirements– for example, medicines legislation, the NHS terms of service, the Equalities Act 2010 and health and safety legislation.

All pharmacists and pharmacy technicians should also become familiar with these standards, and understand that they have a professional responsibility to raise concerns if they believe the standards are not being met.

Patients and the public can read the standards to understand what they should expect from registered pharmacies.

Throughout this document we use the term ‘pharmacy services’. This includes all pharmacy-related services provided by a registered pharmacy – for example, the supply of medicines, advice, and services such as smoking cessation and prescription collection and delivery services. These services would also, for example, include a registered pharmacy providing pharmacy services to a care home.

Throughout this document we use the term ‘staff’. This includes agency and contract workers, as well as employees and other people who are involved in the provision of pharmacy services by a registered pharmacy.

Throughout this document we use the term ‘you’. This means:

  • the pharmacist who owns a pharmacy as a sole trader, or
  • the pharmacist who owns a pharmacy as a partner in a partnership, or
  • the body corporate and
  • the pharmacist who is the appointed superintendent pharmacist for a body corporate.

In some limited circumstances (for example following death or bankruptcy), a representative can take the role of the pharmacy owner. In these cases, the appointed representative will be responsible for making sure these standards are met.

The structure of this standards document

We have grouped the standards under five principles. Under each principle there are three sections:

  • the principle itself
  • the standards for that principle
  • examples of how you would show compliance with those standards.

The principles

The principles are the backbone of our regulatory approach. They are all equally important and must be met.

Principle 1: The governance arrangements safeguard the health, safety and wellbeing of patients, the public and members of staff.

Principle 2: Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public.

Principle 3: The premises where pharmacy services are provided, and any associated premises, are safe and suitable.

Principle 4: The management of medicines and medical devices safeguards the health, safety and wellbeing of patients and the public.

Principle 5: The equipment and facilities that are available are safe and suitable.

 

 

The standards

The standards are requirements that must be met when you operate a registered pharmacy. Responsibility for meeting the standards lies with the pharmacy owner. If the registered pharmacy is owned by a body corporate (for example a company) the superintendent pharmacist also carries responsibility, along with the company.

 

Compliance indicators

This section gives examples of how you can show that you have met the standards we have set. This is not a complete list. For some of our standards, the compliance indicators we have set out may be the only way that you can demonstrate you have met our standards. In other cases, the compliance indicator may be one of a number of ways that you can demonstrate you have met our standards.

Whether you use these indicators or a different approach, you must be able to demonstrate that our standards have been met. Documents serve essential governance, management and legal purposes. But our fundamental concern is with what you do, rather than what you write.

 

Applying the standards

The principles for registered pharmacies, and the standards, are all equally important. You therefore need to read them in their entirety.

We know that a pharmacy owner, and/or superintendent pharmacist, may be accountable for one, a few or a large number of registered pharmacies. We expect the pharmacy owner and/or superintendent pharmacist to make sure that these standards are met whatever the number of pharmacies they are accountable for.

If you are accountable for more than one pharmacy, we recognise that you may need to have management structures in place to make sure that our standards are met.

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