30-1_Pharmacy_regulation_4-1_-_Pharmacy_premises_BB_2023-24

Pharmacy Regulation Overview

  • Focus: GPhC Standards for Registered Pharmacies, Inspectorate Law

  • Presenter: MPharm Professor Ellen Schafheutle

Intended Learning Outcomes

  • Understand GPhC Standards for Registered Pharmacies

  • Familiarize with the GPhC Inspectorate and their powers

  • Legal foundations:

    • Pharmacy Order 2010, Part 3

    • The Pharmacy (Premises Standards, Information Obligations, etc.) Order 2016

    • The Pharmacy (Commencement) Order of Council 2018

GPhC Standards for Registered Pharmacies

  • Standards include:

    • Governance arrangements for managing and monitoring pharmacy services

    • Working environment and conditions of pharmacies

    • Patient and public experience with pharmacy services

    • Condition of equipment and facilities

    • Staff training and accountability for health and safety

Definitions of Key Terms

  • Pharmacy Services: Services provided at or from a registered pharmacy including management of medicines and clinical services.

  • Staff: Encompasses agency and contract workers alongside employees involved in pharmacy services.

Responsibility for Meeting Standards

  • Owners are accountable for ensuring safe service provision.

  • If a body corporate owns it, directors must ensure standards are met.

  • Registered professionals need to be familiar with these standards and must raise concerns if standards are unmet.

GPhC Standards for Registered Pharmacies – 5 Principles

  1. Governance Arrangements

  2. Competence and Empowerment of Staff

  3. Environmental Condition of Premises

  4. Delivery of Pharmacy Services

  5. Safety of Equipment and Facilities

Principle 1: Governance Arrangements

  • Essential for safeguarding health and safety:

    • Clear definitions of roles and accountabilities

    • Risk management procedures

Principle 2: Empowered and Competent Staff

  • Staff must be competent and empowered to maintain safety and well-being in pharmacy practice.

Principle 3: Environment and Conditions of Premises

  • Premises must be:

    • Suitable for provided services

    • Ensure public health, safety, and well-being

Principle 4: Delivery of Pharmacy Services

  • Covers management of:

    • Medicines, advice, referrals, and clinical services

Principle 5: Equipment and Facilities

  • Mandates availability of safe and suitable equipment and facilities necessary for service provision.

GPhC Guidance for Registered Pharmacies

  • To support standards, including:

    • Equality guidance (Dec 2022)

    • Guidance on ensuring an effective pharmacy team (June 2018)

    • Guidance for services at a distance (Mar 2022)

    • Unlicensed medicines guidance (Aug 2018)

Guidance on a Safe and Effective Pharmacy Team

  • Outlines responsibilities for:

    • Pharmacy owners and professionals (pharmacists & pharmacy technicians)

    • Unregistered staff (dispensers, counter assistants, etc.)

GPhC Guidance for Distance Pharmacy Services

  • Includes face-to-face and distance services:

    • Prescription collection and delivery options

    • Use of technology such as automated Rx collection and click-and-collect services.

    • Mail-order services and internet pharmacy services (hub and spoke model included).

Hub & Spoke Model

  • Visual representation can be found at the provided link.