Following a report from the Pharmacists' Defence Association (PDA) suggesting the General Pharmaceutical Council (GPhC) is employing a ‘light touch’ around regulating pharmacy owners, we talk to the PDA and GPhC about the standards.
Alison Jones, director of policy at the PDA, told The Pharmacist the body has heard ‘some concerns around where the GPhC has determined that standards have been met’ in inspection reports, despite occasions where inspectors have uncovered issues around workload and wellbeing.
However, Ms Jones said inspection standards were met even when pharmacy team members ‘were a few days behind on their workload’, meaning ‘they occasionally stayed behind after the pharmacy closed when there wasn’t a responsible pharmacist present’ to catch up.
She continued: ‘Team members are working without pause or respite. They often found it difficult to allow time to speak to the inspector and a significant portion of the inspection there was a queue of four or five people waiting to be served, but they still met the standards.
‘Our concerns are where the regulator will say standards have been met but then the narrative highlights some of these issues – where is that bar?’
Workload concerns in busy pharmacies
Ms Jones stressed that workforce shortages, lack of protected training time and workload were concerns members were raising repeatedly with the organisation, which has its own charter of seven safety standards including safe staffing, no self-checking and adequate rest.
‘It’s potentially a symptom of reduction in funding for community pharmacy operators, but the funding therefore needs to be in place to make sure the pharmacy can operate safely with enough staff, including support staff, to deliver a good service,’ said Ms Jones.
She added: ‘There probably is a driver to keep the costs down in terms of how they operate the pharmacy because the funding potentially is an issue, but there’s the attractiveness of the job itself as well. If you look at violence and abuse that people are experiencing in pharmacies, it paints a picture, and if people aren’t getting the adequate training, they may choose to work elsewhere…
‘If you have a commitment to deliver a service on behalf of the NHS, you have to staff it appropriately to provide that good level of service, which means offering all of the services in the contract and providing a good environment for the people that work there.’
‘GPhC does make workforce assessments’
In a statement to The Pharmacist, the GPhC countered that while it does not have a regulatory role in workforce planning, it does make ‘an assessment of whether there are enough staff of the right skills to carry out the tasks in the pharmacy’.
It added: ‘We also work closely with the organisations that lead in the area of workforce planning, including the governments, NHS and strategic education bodies in each of the countries in which we regulate, to make sure we understand the current context and key issue.’
The spokesperson stressed that the GPhC does not have a ‘direct role’ around financial, labour market or contractual issues including temporary pharmacy closures, and focuses instead on regulating pharmacies on patient safety, and whether it is operating safely and effectively.
But it said: ‘However, we are committed to working collaboratively with the PDA and all involved to develop a system-wide approach to the complexities around these issues, so that pharmacies across Great Britain are meeting the expectations and needs of patients and the public.’
The GPhC explained that it expects pharmacies to meet its standards every day and requires pharmacies to provide evidence of how they meet standards during inspections.
It said that, during inspection, inspectors ‘gather evidence and record evidence in a number of ways’ to determine whether a pharmacy has met all its standards, including:
- Looking at written or documentary evidence
- Observing interactions with patients
- Asking questions and posing scenarios to staff
- Testing systems, processes and procedures.
When making a judgement, inspectors will ‘consider the impact and scale of the weaknesses or areas for improvement identified’, the spokesperson said.
They continued: ‘The greater the impact on patient safety, the more likely it is that the standard will not be met. While relatively minor issues are unlikely to result in a standard not being met, there may be a cumulative impact of relatively minor multiple individual shortcomings which could lead to the conclusion that a standard is not met.’
GPhC inspections consider the GPhC’s Inspection Decision-Making Framework – which is a guide to support inspectors to make consistent decisions - and the Inspection practice note 1: Minor non-compliance when assessing if a pharmacy has met the standards, it added.
When a pharmacy has not met one or more of the standards, it is required to complete and implement an improvement action plan (IAP). If the GPhC does not receive the required evidence of improvement through an IAP, it would escalate to statutory enforcement.
What do the standards require?
The GPhC standards are grouped under five principles: that governance arrangements; the environment and condition of the premises; the way in which services are delivered; and the equipment and facilities used, all safeguard the health, safety and wellbeing of patients and the public, and that staff are also empowered and competent to ensure this safeguarding.
Principle 1: ‘The governance arrangements safeguard the health, safety and wellbeing of patients and the public’
‘Governance arrangements’ includes having clear definitions of the roles and accountabilities of the people involved in providing and managing pharmacy services. It includes the arrangements for managing risks, including a full set of written procedures for team members to follow.
The risks associated with providing pharmacy services should be identified and managed, and the safety and quality of those services reviewed and monitored. Staff should be provided with clear lines of accountability and be able to raise feedback and concerns, which will be taken into account and action taken where appropriate.
This principle also includes a site having appropriate indemnity or insurance arrangements; for all necessary records for the safe provision of pharmacy services to be kept and maintained; and information managed to protect the privacy, dignity and confidentiality of patients and the public.
Principle 2: ‘Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public’
There must be enough staff, suitably qualified and skilled, for the safe and effective provision of the pharmacy services provided; while incentives and targets should not compromise the health, safety or wellbeing of patients and the public, or the professional judgement of staff.
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’
All premises where pharmacy services are provided should be safe and suitable – this means clean, tidy and properly maintained, as well as protecting the privacy, dignity and confidentiality of patients while being secure and safeguarded from unauthorised access.
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.’
This includes the management of medicines, for example arrangements for obtaining, keeping, handling, using and supplying medicinal products and medical devices, as well as security and waste management. Medicines should be obtained from a reputable source, safe and fit for purpose, stored securely, safeguarded from unauthorised access, supplied to the patient safely, and disposed of safely and securely. They must be labelled accurately and dispensed with the required information, while returned medicines and sharps bins must be disposed of in a timely manner.
Principle 5: ‘The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public.’
Equipment and facilities should be readily available, as well as obtained from a reputable source, safe to use and fit for purpose, stored securely, safeguarded from unauthorised access and appropriately maintained.
This comes after the GPhC confirmed this month that there has been an increase in fitness to practise (FtP) action being taken against pharmacist prescribers associated with certain types of online prescribing services.