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Regulations

Regulations cover three elements GPhC, Controlled Drugs Guidance, and GDPR

GPhC Regulations

The General Pharmaceutical Council (GPhC) is the regulatory body for Pharmacy professionals and premises in the UK. Their key roles are to protect the public and to drive improvement in the profession. They do this in a number of ways:

  • Maintaining a register of practicing pharmacy professionals and active premises

  • Inspecting pharmacy premises

  • Setting practice standards and ensuring that they are upheld

  • Providing practice guidance where possible

  • Promoting professionalism

  • Dealing with concerns raised about registrants

  • Exercising their enforcement powers where necessary

This page highlights some useful resources for pharmacy teams.

Revalidation

In 2017, the GPhC changed the way that Pharmacists and Pharmacy Technicians retain their registration each year. Registrants are now required to undergo a mandatory revalidation process each year, which helps to show the public that the trust that people have in the profession is well placed.

This involves each pharmacy professional submitting CPD records and other reflective accounts before they are able to renew their registration. Feedback so far has shown that this is a straightforward exercise and is generally preferred to the previous arrangements.

Find out more about Revalidation

Regulate

Regulate is the GPhC’s regular news publication for registrants, covering the latest news and developments.

Read Regulate online

Standards

The GPhC set the standards for conduct, ethics, and performance which describe the behaviours, attitudes, and values expected of pharmacy professionals and services. They inform the basis of premises inspections, help the profession to gauge performance, and also inform patients and the public of the standards that they can expect of pharmacy professionals. The standards for initial education and training of pharmacy professionals are also laid down by the GPhC.

Each set of standards is supported by specific guidance for areas of practice that professionals may require additional support in applying the standards to – for example, guidance is provided on how to interpret the standards when it comes to religion, personal values and beliefs in relation to the provision of pharmacy services.

Read current GPhC standards and guidance

Community Pharmacy Inspections

Following a consultation exercise, the GPhC has changed its approach to inspecting registered premises. For the most part, the content of individual inspections will not look much different than those which are carried out now, but the main changes will be:

  • As a general rule, inspections will now be unannounced

  • The outcome of inspections will now be either that a pharmacy has met all of the standards for safe and effective practice, or it has not met all of them.

    • Good and Excellent practice will still be highlighted in reports where appropriate

  • Inspection outcomes, reports, and action plans will be published on a new website from later in 2019 onwards. Historical reports will not be published.

  • All pharmacies will still be inspected within a (roughly) 4.5-year period. However, the order and frequency of inspections will be risk-based. Put simply, pharmacies which have previously received ratings of Poor or Satisfactory with action plans will be inspected sooner than those which were rated Excellent or Good under the previous approach to inspections.

  • Two new types of inspection – intelligence-led and themed – will be introduced

    • Intelligence-led inspections will utilise the information that the GPhC is provided to prioritise inspections. This might be following concerns being raised about a premises or registrant, or analysing data to characterise certain circumstances or trends that create problems for pharmacy teams and targeting resources to those experiencing them.

    • Themed inspections will focus narrowly on specific themes, issues, or types of registrant/premises and will be more in-depth than an ordinary inspection. These will help to identify and spread good practice as well as further explore common areas for improvement.

There are several useful resources made available by the GPhC here. The decision-making framework is a particularly useful tool to help you think about your operations from an inspector’s point of view.

We will add more information on inspections here as it becomes available.


Controlled Drugs Guidance

We produced this page in conjunction with the Controlled Drugs Accountable Officers Network to support best practices when managing controlled drugs.

The Controlled Drugs Accountable Officers’ (CDAO) Network has web pages hosted on NHS Education for Scotland (NES) Knowledge Network. These contain a wide range of documents, guidance, and information relating to the management of CDs and should be referred to as an additional resource.

If you have any queries regarding this or any other Controlled Drug issues please get in touch with your local NHS Board Accountable Officer (AO)/CD team. Contact details are available on the Health Improvement Scotland (HIS) website.

Inter-Pharmacy Controlled Drug Transfers

Although not a legal requirement, if transferring CDs between pharmacies for any reason a CDRF (CP) Form should be used as the signed order by the requesting pharmacy. The supplying pharmacy should then submit the original to PSD for processing. This form has recently been updated to make it more user-friendly. 


GDPR

The General Data Protection Regulations (GDPR) are new EU laws that aim to unify and strengthen data protection for all individuals in the European Union and the UK. These came into effect on the 25th of May 2018.

The Data Protection Act 2017 replaces the DPA 1998 and describes how some parts of the GDPR are applied in the UK. It also covers some areas which the GDPR does not. Together, these two pieces of legislation seek to modernise the way in which data should be handled to reflect the ways in which organisations now use personal information, which was unforeseen when previous data protection laws were written. 

Our GDPR pack which you can access below will help you to work towards compliance with the change in data protection regulations. Data protection will still be regulated by the Information Commissioner’s Office (ICO).

GDPR Pack

Our GDPR pack will help you to work towards compliance with the upcoming change in data protection regulations. This is in four parts as follows:

  1. Guidance – Full background information

  2. Summary Guidance – A handy quick reference guide

  3. Workbook – By working through this, you will be able to demonstrate compliance

  4. FAQs

We would like to thank the UK GDPR Working Group for the source material, which has been adapted and added to for use in Scotland.

These are very much live documents, and we will update them as we receive feedback from you and as we continue to learn about GDPR in practice.

On reading the documents through, if you have any further questions please contact Adam in the Policy and Development department.

Questions

If you have any questions on GDPR, please contact Adam in our Policy and Development team.