Sent: Wed Aug 16 2023 11:26:27 BST Subject: General Pharmaceutical Council CAS-21012-J9Q7F8 Outcome of concern

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Thank you for contacting us with your concern about Orchard 2000 Pharmacy which we received on 10 July 2023.

We are grateful for you having shared this matter with us, as it has provided important information about what is happening in pharmacy practice.

Who we are and what we do As you may be aware, the General Pharmaceutical Council (GPhC) is the regulator for pharmacy professionals and registered pharmacy premises in Great Britain. The GPhC can consider concerns which indicate that a pharmacist or pharmacy technician may not to be fit to practise. Fitness to practise is about someone having the required skills, knowledge, character and health to do their job safely and effectively. A pharmacy professional may not be fit to practise for a number of reasons, for example, if their behaviour is putting patients at risk, they are practising in an unsafe way, or their health may be affecting their ability to make safe judgements about their patients. Not every concern which people tell us about, no matter how justified, will be something that is serious enough to call into question a pharmacy professional’s fitness to practise. In addition, not all those who work within a pharmacy company, such as delivery drivers, are required to be registered professionals, and our role only covers individuals who are registered pharmacists or pharmacy technicians. In relation to pharmacy premises, we have a team of Inspectors who make sure that pharmacies and their systems are being run properly, and that their staff are appropriately trained. If issues are identified, action can be taken to put things right. Our decision about your concern Within your concern you told us about issues in relation to an incident involving a delivery driver for the pharmacy leaving a patient unattended who had injured themselves after a fall. This matter relates to pharmacy support staff. The roles and responsibilities of pharmacy support staff, such as delivery drivers, will be defined by the pharmacy. They, however, must be suitably qualified for the roles that they do. GPhC requirements for the education and training of pharmacy support staff, includes being able to recognise and raise appropriate safeguarding concerns, particularly involving vulnerable adults. However, delivery drivers would not be expected to receive training specifically with how to manage a situation where a service-user has had a fall at home, and would also not normally enter patient’s homes. From what has been described to us, on this occasion it does appear that there has been a failure to safeguard a vulnerable service-user. As the issues you have raised fall more into the category of how the pharmacy is being operated, we have referred the matter to our local Inspector who covers this particular pharmacy. They will assess the risks posed by the issues you have described, and determine what follow- up action may be appropriate. The Inspector will also factor this information into their decision-making

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around the timing of any inspections for this pharmacy, and what the focus of any inspection activity ought to include. The role of our Inspectors is to ensure that the systems and processes within pharmacies meet our standards for registered pharmacies, including the skills and competence of the staff working there. If we find problems, we will ensure improvements are made. We will also be writing to the Superintendent pharmacist (SI) for the pharmacy, to remind them that it is their responsibility to ensure that the training and competencies of support staff are in accordance with the requirements outlined earlier. We will also keep your concern in our records because we may need to consider it if we get any further concerns about the pharmacy. Thank you again for raising this concern with us; it is very helpful to have this information. It would be very helpful if you could tell us about how you feel we have dealt with this concern. If you would like to do so, please fill in the feedback survey at:

Kind regards

Assessment Officer Concerns General Pharmaceutical Council 25 Canada Square | Canary Wharf | London |E14 5LQ

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Concerns General Pharmaceutical Council Level 14, One Cabot Square | Canary Wharf | London |E14 4QJ Email: concerns@pharmacyregulation.or

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Dear Mr Steele Regulation 28 Report to Prevent Future Deaths – Harold Wilberforce (Ref: 2023-0235) Thank you for sharing the recent Regulation 28 Report relating to the death of Mr Harold Wilberforce. We are very sorry to hear about this and we would like to pass on our sincere condolences to Mr Wilberforce’s family. We note your concerns about a lack of clarity in respect of the roles and responsibilities of persons (such as delivery agents/drivers) attending upon the home addresses of elderly service users, particularly in the context of what action should be taken when someone is found to have fallen. It may be helpful if I provide some background and context to our role as the independent regulator for pharmacy in Great Britain. The GPhC has a statutory purpose to protect patients by setting and upholding the standards for registered pharmacies and the standards for pharmacy professionals to ensure that registered pharmacies are safe to provide services, and that pharmacy professionals are fit to practise. We also publish guidance and other good practice, to support pharmacy owners and pharmacy teams to meet our standards. In addition, we inspect pharmacies to make sure they are meeting our standards, and we investigate concerns about the people and pharmacies we register, taking proportionate action to protect the public. Through our inspections, we look at a pharmacy’s activity and the way it operates as well as the services it provides. When a registered pharmacy provides a delivery service, this is one aspect of the pharmacy services that we would look at and assess against the requirements of our standards for registered pharmacies. When reviewing services that involve the transportation of medicines to a patient’s home, we consider a number of different areas. This includes our Inspection decision making framework , the Findings pharmacyregulation.org | |

framework and our guidance for registered pharmacies providing pharmacy services at a distance, including on the internet. One of the core requirements in our standards is for pharmacy owners to ensure that risks associated with the services they provide are identified and managed. Inspectors will look at the systems and processes for secure delivery to people receiving care, for example, how medicines are transported and who provides the service. This includes looking at standard operating procedures (SOPs) and arrangements for indemnity insurance. They will also look at how pharmacy owners are assessing and managing risks, for example, risks associated with the suitability and timescale of the method of delivery or managing unexpected interruptions in delivery. Inspectors will also check the training provided to delivery agents/drivers and the pharmacy team. They will also usually ask about delivery arrangements and service level agreements with transportation providers. We note your concerns about the actions of the delivery driver in this case and the pharmacy’s lack of training for staff about what to do if a service user is found to have had a fall at their home address by a pharmacy delivery agent. Delivery drivers themselves are not registered or directly regulated by us; nevertheless we have published guidance to ensure a safe and effective pharmacy team and we set requirements for the training of unregistered staff (which includes delivery drivers). Our guidance states that pharmacy owners are responsible for making sure that the whole pharmacy team – both registered pharmacy professionals and all unregistered staff – provide safe and effective care and pharmacy services. 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. Pharmacy owners are also accountable for making sure their unregistered staff meet our requirements for training. The scope of work of pharmacy support staff is hugely diverse, so we do not mandate specific detail about particular scenarios. We specify a set of learning outcomes which all support staff must achieve. These include outcomes relating to:
• Acting to maintain the interests of individuals and groups, making patients and their safety their first concern;
• Listening to and communicating effectively with users of pharmacy services;
• Recognising and raising concerns about safeguarding people, particularly children and vulnerable adults;
• Referring issues and/or individuals as appropriate to another member of the pharmacy team, other health and social care staff, organisations and services. In this case, the Superintendent Pharmacist (SI) for the pharmacy has advised our inspector that all team members, including the delivery drivers, across the company had been made aware of the incident. The SI explained the SOPs had been updated to make it clear for the delivery drivers how to respond to an emergency which may arise when delivering medication. This included contacting the emergency services and informing the pharmacist on duty. The updated SOPs had been shared with all the delivery drivers and other team members across the company. The SI informed the inspector that all the drivers were enrolled on to a specific training course provided by an accredited pharmacy training provider and they were being supervised by the pharmacy managers across the company as they completed the training.

We will also remind our inspectors to make sure that they include, through our ongoing inspections, discussions about whether a pharmacy has SOPs in place to support delivery agents/drivers and wider teams to know what to do and who to contact if they find that a service user has had a fall or is at risk in other ways. The inspectors do currently routinely ask about how pharmacies ensure that children and vulnerable adults are safeguarded. This means that we can check if pharmacies are proactively considering how to manage the risks associated with these situations. I hope this is helpful and please do not hesitate to get in touch if you need anything further at this stage.

Dear Mr Steele Thank you for sending us your report and recommendations following the inquest of Harold Wilberforce. We have noted your concerns relating to the prescription delivery agent who attended and provided support for him in the immediate aftermath. We noted that Mr Wilberforce resisted attempts by the delivery agent to contact emergency services. We also noted your comments on training provided to pharmacy staff when they come across patients who have suffered a fall. We noted your concern about lack of clarity relating to the roles and responsibilities in relation to actions to be taken when someone is found to have fallen.

As a responsible organisation providing vital services to our service users, a significant proportion of whom are elderly, we have a standard operating procedure in place relating to delivery of medications. Our delivery agents are mandated to go through this SOP and adhere strictly to it in all circumstances. The SOP is drawn up to in line with best practices by the National Pharmacy Association who we are a member of. We noted during our review that there was no mention of what to do in an emergency which may arise during delivery of medications. As an organisation, we have taken steps to address this by making our delivery agents aware of their duty to contact emergency services and inform the pharmacist on duty as soon as practical. We have also contacted our staff training providers, The NPA, to identify any necessary update course for our delivery agents. They have responded by making us aware of a training programme titled: Delivering Medicines Safely and Effectively. We have reviewed the content of the course and are satisfied that this covers all the concerns and provides clarity for our staff in these circumstances. We have now enrolled all our delivery agents for this programme and they are being supervised by our pharmacy managers to ensure completion and support with the programme. We do hope that our response has demonstrated our commitment to the provision of excellent care for our service users and we are committed to evaluating this from time to time as well as seeking out any other necessary training programmes.

56 High Street, Normanton WF6 2AQ, Wakefield, West Yorkshire, England

We want to take this opportunity to offer our condolences to the family of late Mr Harold Wilberforce who have demonstrated incredible resilience during this difficult time. We would be grateful if a copy of this letter is also sent to the family of late Mr Wilberforce as we do not have their contact details. Kind regards,

Director