Developing a model that fits your pharmacy needs
Where possible, it’s important that discussions and collaboration occur between the pharmacist, pharmacy team, line managers, pharmacy owners and SI to identify needs and requirements, and to design, deliver and test new ways of working or any interventions.
If you wish to operate under a model that enables the facilitated self-selection of P medicines, then key safeguards need to be in place to ensure sales of P medicines can be managed safely and appropriately. Safeguards may include using technology to prevent inappropriate sales being completed, or safeguards relating to staff roles, responsibilities and training as well as ongoing team learning.
Safeguards
Here are some safeguards you may want to consider putting in place to help address risks that may have been identified:
Assigning roles and responsibilities
Everyone in the pharmacy team should have a clear understanding of their role and responsibilities if delivering a facilitated self-selection model for P medicines.
Decisions around roles and responsibilities should be made at an appropriate level, e.g., individual premises/local/regional/organisational level and can vary depending upon the situation.
Roles and responsibilities should be covered in the pharmacy SOPs and tasks should be delegated after appropriate training has been provided. The person delegated for the role or task should have the appropriate skills, qualifications and competence.
In relation to facilitated self-selection P medicines, here are the roles and responsibilities expected in addition to the GPhC standards and guidance, best practice guidance and internal/organisational SOPs.
SI and pharmacy owner are typically responsible for:
The pharmacist is typically responsible for:
- The RP retains ultimate professional responsibility for the safe operation of the pharmacy on the day(s) they are appointed
- Ensuring you are comfortable working in a pharmacy that operates a facilitated self-selection model for P medicines before accepting employment (employed or self-employed)
- Ensuring the safe and effective day-to-day running of the model
- Reading and signing the relevant SOPs for the model – any decision not to follow SOPs must be a professional judgement, based on risks, patient safety, etc.
- Considering the risks of implementing any actions, such as closing off facilitated self-selection areas, or changing which P medicines are available for facilitated self-selection, as this may be confusing for people accessing medicines and members of the pharmacy team
- Ensuring sales of P medicines for self-selection are made in line with GPhC standards for registered pharmacies, this includes the need for appropriate questioning to ensure the medicine(s) are suitable for the person requesting
- Managing risks identified in the pharmacy and ensuring they have been mitigated or minimised and patient safety is maintained
- Raising concerns using the appropriate channels if you believe the GPhC standards are not being met – you may find our raising concerns guide helpful
- Raising concerns about the model, P medicines for self-selection, SOPs or risk assessments where relevant and appropriate or making suggestions for amendments by speaking to your SI or their team – see your internal processes and the section on autonomy and raising concerns
- Ensuring you have the right resources in terms of suitably trained staff and putting safeguards in place when you are short staffed, e.g., closing access to P medicines on open displays.
The pharmacy team is typically responsible for:
- Reading, understanding and following relevant SOPs to do with P medicines – see your internal SOPs
- Completing appropriate training as relevant to your role prior to providing the service, with regular refreshers as required to ensure ongoing confidence and competence
- Knowing which medicines are not suitable for sale in your pharmacy by facilitated self-selection – see the section on P medicines that may not be suitable for facilitated self-selection
- Working within your scope and knowing when sales can’t take place, e.g., when the pharmacist is absent – see internal SOPs
- Appropriate questioning and checks to ensure the product that has been selected is suitable and safe
- Contributing to a learning culture in the pharmacy by sharing learning from near misses or incidents
- Raising concerns using the appropriate channels if you believe the GPhC standards for registered pharmacies are not being met – you may find our raising concerns guide helpful
- Referring or speaking to the pharmacist if you’re unsure about anything or if you have any questions before the sale is made.
Autonomy and raising concerns
A pharmacist has autonomy to decide on the day-to-day running of the model ensuring patient safety and service continuity. There may be circumstances where your professional judgement indicates a pharmacy is not safe and effective.
If you have any concerns about existing risk assessments, SOPs, clinical governance policies, or you identify new risks, then these should be raised with the RP (if you are not the RP on the day), SI or their team, owner or head office as soon as possible using the relevant internal processes.
If you have any concerns about a P medicine for self-selection, you can choose not to allow facilitated self-selection of that medicine using your professional judgement; however, you should also take steps to escalate or communicate with the SI or their team, head office or the pharmacy owner effectively. You should also document any actions taken and the reasons why, as good practice, e.g.:
- You make a professional judgement that a certain P medicine offered for facilitated self-selection cannot be safely self-selected or is inappropriate and should be removed to prevent unauthorised access
- You highlight concerns about elements of processes (SOPs), clinical governance or concerns that risks are not safely mitigated
- There are not enough staff with the skills and competence to run the service safely.
The operation of a facilitated self-selection model for P medicines does not override your autonomy to decline, refuse and intervene in sales (where appropriate), or in the use your professional judgment, if a sale of a P medicine is not safe and appropriate as you would in traditional practice. If declining a sale, it is important to explain why in an empathetic way and continue to provide person-centred care by advising on where to access the care that they need, e.g., if they need to be referred to their prescriber. As a pharmacist, you have a professional duty to provide person-centred care.
For further information, you may find our guides on raising concerns as well as our patient safety standards and resources helpful.
Learning, development and training
It’s important the pharmacy team are competent and feel confident to provide person-centred care and ensure the sale of P medicines is safe and effective, irrespective of whether the P medicines are self-selected or not. Standard 2.2 of the GPhC’s standards for registered pharmacies expects that pharmacy support staff involved in the sale or supply of P medicines have the appropriate skills, qualifications and competence for their role, or work under the supervision of another person (either a registrant or another appropriately qualified or experienced individual) while they are in training – for further information, see the GPhC requirements for the education and training of pharmacy support staff.
In addition to existing learning processes and SOPs on the sale of P medicines, SIs and RPs can ensure sufficient knowledge of the facilitated self-selection model for P medicines of anyone delivering pharmacy services or employed within the pharmacy by:
- Making sure all staff understand each other’s roles and responsibilities and knowing when to escalate and refer – see the section on assigning roles and responsibilities
- Assessing competency of staff to ensure they have the appropriate skills, qualifications and competence for their role and the tasks they carry out – for further information, see the GPhC requirements for the education and training of pharmacy support staff
- Identifying learning needs, e.g., an incident can be an indication of a learning need
- Providing training at the right time and intervals (as appropriate), e.g., new starters during inductions to set expectations for delivering the model
- Providing training to deal with the various scenarios that may arise if the sale of a P medicine on self-selection is refused because the pharmacy team consider the medicine unsuitable for the person requesting it or if the person won’t answer any questions – practising roleplay scenarios may help to build confidence for certain scenarios
- Ensuring the pharmacy team have read any relevant new SOPs and training guides, e.g., on the management of risk from P medicine self-selection
- Ensuring the pharmacy team can identify P medicines when brought to the till, ask the appropriate questions and provide counselling on their use to ensure sales are safe and appropriate – see internal SOPs
- Ensuring the pharmacy team can refer people to the consultation room for sensitive discussions – for further information, see the GPhC guide on confidentiality
- Restricting sales of P medicines to specific tills, tills that only appropriately trained pharmacy team members can use to authorise sales or programming tills to recognise P medicines to prevent sales being made by unqualified staff or in an unregistered part of the premises
- Delegating specialist roles to help people with facilitated self-selection, e.g., these staff members may have an NVQ level 2 qualification as a minimum.
To support these conversations, good communication is essential. Develop your confidence with practical tips and information in our consultation skills pharmacy guide and our consultation skills e-learning module. For all our other e-modules see here.
Clinical governance framework and SOPs
It’s important for SIs and pharmacy owners to develop a clear clinical governance framework to demonstrate that you are effectively controlling sales through the facilitated self-selection model for P medicines.
You will already be doing this for the sale of P medicines if you are using a traditional model. However, here are some considerations to help SIs demonstrate this if you adopt the facilitated self-selection model (the list isn’t exhaustive and there may be others identified through audits and risk assessment):
- Indemnity – GPhC standards for both registered pharmacies and pharmacy professionals state you must have appropriate indemnity cover for services provided
- Pharmacy owners and registrants who have their own indemnity cover should inform their indemnity providers when any changes are made to the operation of the pharmacy that may affect the level of risk involved in providing services. For further information or questions, contact your insurers directly.
- Audit – For further information on audits, you may find our guides on clinical audit, service evaluation and quality improvement helpful
- Regularly audit sales to identify any problems and to review current processes, sales and the P medicines not suitable for facilitated self-selection. Comparing against before you implemented the model can help you see if the model is working, and help you identify any problems
- Look for trends locally or nationally, e.g., to identify P medicines that are misused to add to the list
- Audits can be used to develop robust risk assessments and iterate on these
- Gather feedback from staff delivering pharmacy services – e.g., capturing instances where there is aggression from people linked to self-selecting an inappropriate P medicine. This will help build up the evidence base to show if this model is safe and effective or risky
- Conduct ongoing research into the risks and benefits of the facilitated self-selection of P medicines in real-world practice.
- Continuing professional development (CPD) – see the section on learning, development and training
- Involving people who use your pharmacy services – get feedback on how the facilitated self-selection model of P medicines is going, e.g., through surveys
- Staff management – see the section on assigning roles and responsibilities and learning, development and training
- Risk management – see the sections on how to implement facilitated self-selection of P medicines safely and the risk assessment of P medicines not suitable for facilitated self-selection to help you develop robust SOPs from risk assessments
- SOPs – all members of the pharmacy team who are involved in the sale of P medicines must follow the pharmacy’s SOPs for recommending and selling P medicines and providing advice about the use of these medicines, irrespective of whether the P medicines are self-selected or not. This includes both when responding to symptoms and when a product is presented for sale. Pharmacy team members should know when referral to the pharmacist is required
- General Data Protection Regulation – it's important to take steps to protect and maintain people’s privacy, dignity and confidentiality by ensuring staff are appropriately trained and that there is access to a consultation room or similar private space for sensitive discussions irrespective of whether the P medicines are self-selected or not – for further information, see the GPhC guide on confidentiality.
For further information on clinical governance requirements, you may find our guide on clinical governance helpful.
If a pharmacist makes a professional judgement that the SOP cannot be implemented safely or has any concerns, they should notify the SI or their team. This will allow the SI to review the concerns raised, make any necessary changes and share best practice with other pharmacies. The pharmacist should ensure that the person requesting the medicine is signposted to the appropriate place to receive the care they need, which may be their prescriber. For further information, see the section on autonomy and raising concerns.
P medicines that may not be suitable for facilitated self-selection
A risk assessment should be run to identify which medicines would not be suitable for facilitated self-selection in your pharmacy (see below). These medicines will differ for each pharmacy and should be set out in the SOPs and clinical governance, considering factors such as risks and demographics. This is important to ensure the pharmacist and pharmacy team know which P medicines are not suitable for facilitated self-selection in the pharmacy they work in, and any concerns are raised early.
The SI should set out which medicines are suitable for facilitated self-selection and would need to ensure appropriate safeguards are in place to manage sales of these medicines, e.g., you may decide to lock these medicines away or keep them behind a counter. It’s important for the SI and pharmacy owner to listen to, engage and collaborate on innovation with their teams (where appropriate) before they implement the model and during reviews.
There may be circumstances where pharmacists make a professional judgement that certain P medicines usually offered for facilitated self-selection are inappropriate or cannot be safely self-selected. Pharmacists would need to ensure appropriate safeguards are in place to manage these. For further information, see the section on autonomy and raising concerns.
Higher-risk medicines
Here are some higher-risk P medicines which may not be suitable for facilitated self-selection in the pharmacy you are working in. Higher-risk medicines may include the following (there may be other medicines identified that you may wish to add):
- Medicines that:
- Are liable to problematic use, abuse or misuse, e.g., laxatives, pseudoephedrine, sleep aids, opioids, cyclizine
- Have an increased risk of more severe side effects or adverse drug reactions
- Have an increased risk of serious harm if taken in overdose, including medicines referenced in patient safety reports and prevention of death reports.
- Medicines susceptible to shoplifting or theft
- Recent POM to P switches.
Risk assessment of P medicines not suitable for facilitated self-selection
A risk assessment can help to identify which P medicines would not be suitable for self-section in your pharmacy. It may look like this:
Step 1
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Local risk factor assessment
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Conduct a baseline assessment of the use of P medicines in your pharmacy to identify high risks, e.g.:
- Look at issues in your local area or population (e.g., opioids overuse, theft of high-value medicines)
- May be person-specific as some medicines are riskier to some than others
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Step 2
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Product risk factor assessment
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Conduct a baseline assessment of individual P medicines stocked in the pharmacy. Identify higher risks, e.g.:
- Therapeutic risk – where there is a higher risk of harm if the medicine isn’t used as intended (e.g., sleep aids and laxatives)
- Risks of under counselling – where it’s important to explain further information, e.g., the method of administration, contraindications, side effects to look out for, when to seek medical attention, required follow ups and referrals, the effects on fertility, pregnancy, lactation and driving.
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Step 3
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Consider input measures from:
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- Incidents, thefts, customer reports, colleague feedback (proactively invited), horizon scanning and emerging trends (e.g., suggestions that certain medicines are being misused/abused)
- Document and act as necessary to continue to manage risk.
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Step 4
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Identify and implement risk reduction measures
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You may wish to describe the action(s) you have taken to minimise or avoid the risks you have identified, e.g.:
- Ensuring the pharmacy team is trained to identify and deal with the sale and supply of these higher-risk P medicines in the context of the facilitated self-selection model
- Using prompts like a laminated list by the till to highlight higher-risk P medicines at the point of sale, to prompt discussions on counselling and to support team members in training
- Securing high-risk P medicines that are liable to abuse or misuse, problematic medicines or medicines susceptible to shoplifting or theft. For further information, see the section on premises and security.
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It’s important for SIs to:
Premises and security
Pharmacy owners and SIs should ensure their premises are suitable for the facilitated self-selection of P medicines. This is to ensure they are meeting the GPhC Standards for registered pharmacies. The model must operate in an environment that is compliant with all regulatory standards, which assures public and patient safety.
Here are some examples of premises and security safeguards for potential risks that pharmacy owners and SIs may want to consider putting in place if you wish to operate under a model that enables the facilitated self-selection of P medicines. You may already have these in place for the sale of P medicines if you are using a traditional model, but they may be a useful reminder if you are considering a refurbishment or opening a new pharmacy and want to adopt the facilitated self-selection model for P medicines:
- Ensure you have the space on the shop floor for the P medicines for facilitated self-selection that meets the GPhC Standards for registered pharmacies, e.g., if redesigning the shop floor
- Secure higher-risk medicines where appropriate, e.g., keep medicines which may require additional safeguards out of sight, behind the counter, in the dispensary or in a locked display cabinet that can only be opened by the pharmacy team or replaced by dummy boxes
- Prevent/deter theft, e.g., by installing security cameras and displaying notices
- Make sure people have access to help, e.g., allocating a member of staff on the shop floor at all times to help people and to monitor these medicines
- Prevent sales being made by unqualified staff or in an unregistered part of the premises, e.g., use technology such as till prompts to flag P medicines or limit sales to certain tills and access for certain competent staff to minimise inappropriate sales (where appropriate)
- Secure P medicines for self-selection where pharmacies are located within larger stores with longer opening hours than the pharmacy, e.g., using barriers that shut off access to P medicines displays when the pharmacy is closed (where appropriate)
- Ensure sales of P medicines can only be completed at tills within the registered part of your premises.
Patient safety and education
Raise awareness
To provide person-centred care and ensure patient safety, it’s important that people who use your pharmacy services are made aware of the facilitated self-selection model for P medicines if your pharmacy adopts it.
Examples of raising awareness (where relevant and appropriate) may include:
- Clear signage in the pharmacy
- Videos – for your website and TV screens
- Leaflets – e.g., about self-care and the ways people can access medicines
- Website updates
- Newsletters
- Social media posts
- Surveys.
You may want to consider always having staff on the shop floor available (where appropriate) to help people understand the new model of accessing medicines, approach people to help by asking questions or answering queries or help them select a suitable medicine. People may feel nervous approaching the pharmacy team, so to ensure comfort and confidence, it’s important to always be discreet, non-judgemental and put the person at ease. If the request needs to be referred to the pharmacist by counter staff, they’ll need suitable training to handle such circumstances, and this should also be covered in the SOPs.
Self-care and health promotion
It's important to provide lifestyle and wellbeing advice (where appropriate) when providing advice or at the point of sale. Providing self-care educates and empowers people to manage their own health, while health promotion encourages people to adopt healthy behaviours and lifestyles. This may include delivering other pharmacy services and advising on diet, exercise, smoking cessation, reducing alcohol, stress management, weight management and blood pressure checks.
People can also be signposted to the relevant products manufacturer patient resources, the patient information leaflet and patient websites like:
You may also find our reclassification guide helpful when supplying recent POM to P switches and other reclassified medicines.