GPhC publishes ‘Guidance to ensure a safe and effective pharmacy team’

The General Pharmaceutical Council (GPhC) has recently published ‘Guidance to ensure a safe and effective pharmacy team’[1]. The guidance explains what pharmacy owners should do to ensure a safe and effective team and meet the standards set out under Principle 2 of the standards for registered pharmacies.

What does Principle 2 say?

The standards for registered pharmacies describe how pharmacy professionals can ensure safe and effective care through ‘person-centred’ professionalism. Principle 2[2] states:

‘Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public.’

GPhC says in its standards that the staff at the pharmacy are key to safe and effective practice of pharmacy. They must be competent and empowered to safeguard the health, safety and wellbeing of patients and the public. The responsibility for meeting the standards lies with the pharmacy owner.

Who is a pharmacy owner?

A pharmacy owner can be a registered pharmacy professional or a sole trader pharmacist. If the pharmacy is owned by a corporate body (a company or an NHS organisation), the directors or partners must assure themselves that the standards for registered pharmacies are being met.

What does the guidance say?

The GPhC’s guidance states that pharmacy owners’ first responsibility is to ensure patient safety. This involves ensuring that:

  • ‘each pharmacy has enough skilled and qualified staff to provide safe and effective pharmacy services
  • staff can meet their professional obligations and can raise concerns in an environment which encourages openness, honesty and continuing development’

In order to meet the standards under Principle 2, the guidance provides information in respect of the following areas:

  1. Setting staffing levels and responding to concerns about patient safety

In order to meet the standards the GPhC expects pharmacy owners to, amongst other things, carry out tailored risk assessments, develop a staffing plan and have procedures to make judgement about the appropriate number of staff and the skill mix.

  1. Leadership and management roles

Pharmacy owners are expected to ensure that pharmacy professionals are able to exercise their professional judgement in the interests of the public and patients. This includes understanding the legal and regulatory framework the owners are working in, being familiar with the standards for pharmacy professionals and their professional responsibilities and ensuring that everyone knows and understands the pharmacy’s procedures.

  1. Maintaining a person-centred environment

The GPhC expects that pharmacy owners will ensure that the pharmacy team understands their responsibilities for record keeping and take steps to maintain privacy and confidentiality (including GDPR). The team must also demonstrate good interpersonal skill, amongst other things.

  1. Knowledge, skills and competence

The GPhC sets the minimum training requirements for pharmacy staff. Pharmacy owners must ensure that the staff meets initial education and training requirements and have the appropriate knowledge, skills and competence for their role and tasks, or are under appropriate supervision.

Why is this important?

Pharmacy services continue to evolve and the roles of pharmacy owners and pharmacy professionals continue to change. In order to ensure that pharmacies comply with all legal requirements and regulatory standards, GPhC inspectors have the power to enter any registered pharmacy premises at any reasonable hour in order to conduct an inspection.

The guidance provides useful and important information as an aid to compliance with Principle 2. When looking at whether the standards are met, the inspectors will be looking for evidence that the guidance is being followed.

If you have queries about the contents of this briefing or require any advice related to this issue, please contact:

Michaela Nicholas
Partner
T.
 020 7227 6715
E. michaela.nicholas@rlb-law.com

Stewart Duffy
Partner
T. 
020 7227 7418
E. 
stewart.duffy@rlb-law.com

Ilja Balkus
Trainee Solicitor
T. 020 7227 6748
E. ilja.balkus@rlb-law.com

Footnotes
[1] https://www.pharmacyregulation.org/sites/default/files/document/guidance_to_ensure_a_safe_and_effective_pharmacy_team_june_2018.pdf 
[2] https://www.pharmacyregulation.org/sites/default/files/document/standards_for_registered_pharmacies_june_2018_0.pdf


Disclaimer

This briefing is for guidance purposes only. RadcliffesLeBrasseur accepts no responsibility or liability whatsoever for any action taken or not taken in relation to this note and recommends that appropriate legal advice be taken having regard to a client's own particular circumstances.

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