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Flashcards in GPhC Standards and Guidance Deck (21):


• Regulator for the Pharmacy Profession from 27th September 2010


GPhC functions

• Principal functions include:
– approving qualifications for pharmacists and pharmacy technicians and accrediting education and training providers;
– maintaining a register of pharmacists, pharmacy technicians and pharmacy premises;
– setting standards for conduct, ethics, proficiency, education and training, and continuing professional development (CPD);
– establishing and promoting standards for the safe and effective practice of pharmacy at registered pharmacies;
– establishing fitness to practise requirements, monitoring pharmacy professionals' fitness to practise and dealing fairly and proportionately with complaints and concerns.


Role of GPhC Council

• Defined in article 6 of the Pharmacy Order 2010 as:
– “The main objective of the Council (including its staff and committees) in exercising such of its functions as affect the health, safety or well-being of members of the public is to protect, promote and maintain the health, safety and well- being of members of the public, and in particular of those members of the public who use or need the services of registrants, or the services provided at a registered pharmacy, by ensuring that registrants, and those persons carrying on a retail pharmacy business at a registered pharmacy, adhere to such standards as the Council considers necessary for the safe and effective practice of pharmacy.”


GPhC Standards

– Standards of conduct, ethics and performance
• These set out the behaviours, attitudes and values expected of
pharmacy professionals.

– Standards for registered pharmacies
• These ensure the safe and effective practice of pharmacy at registered pharmacies.

– Standards for continuing professional development (CPD)
• These ensure that pharmacy professionals maintain their knowledge and skills and remain up to date with practice


Standards of Conduct Ethics and Performance
7 principles

As a pharmacy professional, you must:
1. Make patients your first concern
2. Use your professional judgement in the interests of
patients and the public
3. Show respect for others
4. Encourage patients and the public to participate in
decisions about their care
5. Develop your professional knowledge and competence
6. Be honest and trustworthy
7. Take responsibility for your working practices.


GPhC Guidance

• Guidance available as at November 2014:
– Consent
– Maintaining Clear Sexual Boundaries
– Patient Confidentiality
– Raising Concerns
– Provision of pharmacy services affected by religious and moral beliefs
– Responding to Complaints and Concerns
– Responsible Pharmacists
– Professional Duty of Candour
– Demonstrating professionalism on line
– Female genital mutilation: mandatory duty for pharmacy professionals to report

As a minimum be aware of the purpose of and principles in each of these


Standards for CPD

CPD requirements apply equally to all pharmacy professionals.


Standards for Registered Pharmacies

• Approved in September 2012
• Staff covered by the Standard:
– All staff involved in the delivery of services, including
contractors and agency workers
• Who are the standards for?
– a pharmacist who owns a pharmacy as a sole trader;
– a pharmacist who owns a pharmacy as a partner in a partnership;
– a pharmacist who is the appointed superintendent pharmacist for a body corporate;
– the body corporate itself.


Principles in the Standards for Registered Pharmacies

• The health, safety and wellbeing of patients and the public are safeguarded by 5 principles:
– Governance arrangements
– Empowered and competent staff
– Managing the Pharmacy premises
– Delivering pharmacy services
– Equipment and facilities


Principle 1

The governance arrangements safeguard the health, safety and wellbeing of patients and the public.

Governance arrangements include having clear definitions of the roles and accountabilities of the people involved in providing and managing pharmacy services. It also includes the arrangements for managing risks and the way the registered pharmacy is managed and operated.


Principle 2

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

The staff you employ and the people you work with are key to the safe and effective practice of pharmacy. Staff members and anyone involved in providing pharmacy services must be competent and empowered to safeguard the health, safety and wellbeing of patients and the public in all that they do


Principle 3

The environment and condition of the premises from which pharmacy services are provided and any associated premises, safeguard the health, safety and wellbeing of patients and the public.

It is important that patients and the public receive pharmacy services from premises that are suitable for the services being provided and which protect and maintain their health, safety and wellbeing. To achieve this you must make sure that all premises where pharmacy services are provided are safe and suitable. Any associated premises for example non-registered premises used to store medicines must also comply with these standards where applicable.


Principle 4

The way in which pharmacy services including the management of medicines and medical devices are delivered safeguards the health, safety and wellbeing of patients and the public

Pharmacy services covers all pharmacy related services provided by a registered pharmacy including the management of medicines, advice and referral and the wide range of clinical services pharmacies provide. The management of medicines includes arrangements for obtaining, keeping, handling, using and supplying medicinal products and medical devices, as well as security and waste management. Medicines and medical devices are not ordinary commercial items. The way that they are managed is fundamental to ensuring the health, safety and wellbeing of patients and the public who receive pharmacy services


Principle 5

The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public

The availability of safe and suitable equipment and facilities is fundamental to the provision of pharmacy services and is essential if staff are to safeguard the health, safety and wellbeing of patients and the public when providing effective pharmacy services


GPhC Guidance

• providing pharmacy services at a distance, including on the internet
• preparing unlicensed medicines
• Owners and Superintendent pharmacists who
employ responsible pharmacist
• Responding to complaint


The Responsible Pharmacist

Link to GPhC Standards
• This document provides guidance on standard 7.7 of the standards of conduct, ethics and performance which states:
– You must make sure that you keep to your legal and professional responsibilities and that your workload or working conditions do not present a risk to patient care or public safety.


Responsible Pharmacist

• Regulations introduced 1st October 2009
• Every registered retail pharmacy must have to have a ‘responsible pharmacist’
– Where the pharmacy is operating without a responsible pharmacist, it must close for the sale and supply of medicines
– Where there is more than one pharmacist working in the pharmacy, only one is to be the responsible pharmacist at any one time


Responsible Pharmacist

• The responsible pharmacist will have to:
– establish (if they are not already established), maintain and keep under review procedures for safe working;
– keep a record of the pharmacist responsible for the pharmacy at any one time;
– display a notice with the name of responsible pharmacist, their registration number and the fact that they are in charge of the pharmacy.


Required Pharmacy Procedures from 1st October 2009

• Safe and effective management of medicinal products
• The circumstances on which a member of pharmacy staff who is not a pharmacist may give advice about medicinal products;
• The identification of members of pharmacy staff who are, in the view of the responsible pharmacist, competent to perform specified tasks relating to the pharmacy business;
• Arrangements which are to apply during the absence of the responsible pharmacist from the premises;
• Steps to be taken when there is a change of responsible pharmacist at the premises;
• The procedure which is followed if
– a complaint is made about the pharmacy business;
– an incident occurs which may indicate that the pharmacy business is not running in a safe and effective manner; and
• The manner in which changes to the pharmacy procedures are to be notified to the staff;
• The keeping of records about specified matters.


Pharmacy records

• As a minimum, the following details have to be recorded:
– the responsible pharmacist’s name and their registration number;
– the date and time at which the responsible pharmacist became and ceased to be the responsible pharmacist;
– In relation to absence from the premises by the responsible pharmacist:
• The date and start/end times of absence
• If they have been the responsible pharmacist for more than one premises, this fact


Absence from the Pharmacy

• Responsible pharmacist may be absent from the pharmacy for a maximum of 2 hours
– in a 24 hour cycle from midnight to midnight
• They must remain contactable and be able to return with
reasonable promptness.
– If this is not possible another pharmacist must be contactable and available to provide advice.
• Finally, GSL medicines may be sold in the absence of the responsible pharmacist.
– However, if there is no appointed responsible pharmacist then GSL medicines cannot be sold.