FAQ: self-selection and open display of Pharmacy medicines
If you are thinking of changing your displays so that P-Medicines are on open display or are available for facilitated self-selection by patients and the public, or if you simply want to know more about the issues involved, then these FAQs are for you.
These questions and associated answers are not exhaustive as every pharmacy is different, but they are intended to help ensure you consider the risks fully before making any changes.
The GPhC’s position has been that open display of P-Medicines would not be compatible with regulatory standards without key safeguards being in place, including ensuring continued compliance with the legal requirement for pharmacist supervision, and assurance that the arrangements in place secure patient and public safety.
For the purposes of these FAQs, this is where people can pick up P-Medicines themselves without having to ask a team member to either get it for them or open a cabinet. These FAQs do not refer to displays where P-Medicines may be behind clear screens or in a cabinet designed to prevent people from helping themselves. Nor do the FAQs refer to displays of dummy or empty boxes.
We recognise that the language previously used for ‘self-selection’ such as ‘open display’ has not always been helpful, as it could be seen to suggest that the pharmacist and wider pharmacy team would not be involved in the selection and supply of P medicines to the person. We think the term ‘facilitated self-selection’ is more helpful, as it emphasises the crucial roles of the pharmacy team in facilitating the supply of the medicine to the person, and of the pharmacist in supervising the supply. Subject to ongoing review and feedback, we therefore intend to use the term ‘facilitated self-selection’ going forward.
If you have any doubts about whether or not your P-Medicine displays can be accessed without the assistance of suitably trained member of staff, (for example if P-medicines are displayed in boxes or cabinets that could potentially be opened by members of the public) then you should refer to these FAQs
This could include technological solutions to prevent inappropriate sales being completed, or safeguards relating to staff roles, responsibilities and training as well as ongoing team learning. For example, the tills may be programmed to recognise P-Medicines and prevent sales being made either by unqualified staff or in an unregistered part of the premises.
As part of your risk assessment, you should identify any products which you believe may be liable to abuse or misuse, particularly vulnerable to shoplifting or theft, or otherwise problematic. Examples might include any codeine-containing products, recent POM to P switches, some of the sleep aids or any high value medicines. Your risk assessment should describe the action(s) you have taken to minimise or avoid the risks you have identified. For example, you may choose to keep those products out of sight, or in a locked display cabinet.
You should read our standards for registered pharmacy premises and ensure that you meet or exceed them. For example, in order to meet the requirements of standard 1.1 (The risks associated with providing pharmacy services are identified and managed) you should have carried out and documented a comprehensive risk assessment, identifying where things might go wrong. You should specify what action(s) you have taken to mitigate or otherwise minimise each of the individual risks you have identified.
We no longer require you to notify us in advance if you intend to introduce self-selection.
Please contact us via info@pharmacyregulation if you have any queries about introducing self-selection/open display, and ask to be put in touch with your local inspector.
You should read our standards for registered pharmacy premises and ensure that you meet or exceed them. For example, in order to meet the requirements of standard 1.1 (The risks associated with providing pharmacy services are identified and managed) you should update the previous owner’s written risk assessment if its available, ensuring that you are satisfied with any action(s) taken to mitigate or otherwise minimise each of the existing risks, or any new ones you have identified. If there is no written risk assessment available to you, then you should carry out your own risk assessment as indicated in the previous question.
Please contact us via info@pharmacyregulation if you have any queries about self-selection/open display, and ask to be put in touch with your local inspector.
No. The sale of a medicinal product that is not subject to general sale (that is, not a 'GSL' medicine) is subject to the provisions in Section 220 of the Human Medicines Regulations 2012. See the next question for more detail.
P-Medicines must be sold from a registered pharmacy by a pharmacist, or by a person acting under the supervision of a pharmacist. Safeguards should be in place to make sure that sales or supplies of P-Medicines can be managed safely and appropriately. (see the GPhC’s Standards for registered pharmacies, standards1.1, 4.2 and 4.3)
The legal requirement for supervision of activities (the preparation, assembly, dispensing, sale and supply of medicines) taking place in pharmacies in the community and in hospitals defines how pharmacy services are currently provided.
Responsible pharmacists need to be satisfied they are able to appropriately supervise sales of P-Medicines. This does not mean they need to be involved in every sale, but they need to be available to intervene or support pharmacy staff when assessing if the sale of a medicine is appropriate. You should ensure you keep up to date with forthcoming changes to supervision requirements as these may change.
Some of the risks you may want to consider when starting self-selection of P-Medicines include risk of theft of medicines and security and storage of the medicines. Pharmacy owners should ensure their premises are suitable for self-selection of P-Medicines. Owners should also ensure that policies and procedures are available for self-selection of P-Medicines and staff are suitably trained to provide the service.
We don't have an example of a risk assessment as every pharmacy is different and will have different risks that need to be considered. Pharmacy owners wishing to provide self-selection of Pharmacy Only medicines should tailor their risk assessment to their specific pharmacy.
This could include, for example, during lunch breaks, when carrying out a service, sickness absence, of if staff are asked to come into the dispensary to help with dispensing.
Can the medicines be covered up so that they are unavailable for self-selection? Or does a staff member need to be constantly monitoring the P Medicines that are available for self-selection when the pharmacy is open?
The pharmacy must have enough suitably qualified and skilled staff present to supervise sales of P medicines and manage these safely and effectively (see the GPhC’s Standards for registered pharmacies, standard 2.1). In the absence of suitably qualified and skilled staff, appropriate measures must be taken to ensure that any P medicines are safeguarded from unauthorised access if they cannot be supplied to the patient safely.
The Responsible Pharmacist (RP) has responsibility for all activity undertaken within a pharmacy that needs to be carried out under the supervision of a responsible pharmacist. This includes the sale of P-Medicines. The RP needs to be confident they are able to appropriately supervise sales of P-Medicines. Pharmacists have a professional duty to provide person-centred care, however if they are not satisfied that they can appropriately supervise sales of medicines, they may need to consider signposting patients to other providers.
If there is no pharmacist present for any reason, the sale of P-Medicines cannot take place regardless of whether they are available for self-selection or not. Staff members should be aware that the sale of P-Medicines cannot take place when the pharmacist is absent, so there must be procedures in place to prevent unauthorised sale or supply.
Sales of P-Medicines can take place, whether self-selected or not, when the pharmacist is in the consultation room if the following criteria are met:
the pharmacy has robust standard operating procedures (SOPs) in place which detail when pharmacist intervention would be required in the sale of P-Medicines
staff members have ensured that they have followed those procedures and are happy to make the sale, and
the pharmacist is happy for sales to take place when they are in the consultation room, as they will be responsible for any sales of P-Medicines that take place
If staff members are unsure about anything or have any questions, they must be able to speak to the pharmacist before any sale is made.
All members of the pharmacy team who are involved in the sale or supply of over-the-counter medicines must follow the pharmacy’s standard operating procedures for recommending and selling P-Medicines and providing advice about the use of these medicines, irrespective of whether the medicines are self-selected or not. This includes both when responding to symptoms and when a product is presented for sale by a patient. Pharmacy team members should know when referral to the pharmacist is required.
Pharmacies can demonstrate they are effectively controlling sales by creating robust risk assessments and standard operating procedures for its team members to follow. A pharmacy would also need to demonstrate that its staff:
have the correct training to identify P-Medicines when brought to them by people for purchase, and
are able to ask the appropriate questions to ensure sales are safe and appropriate
Till prompts or other technology may help support pharmacy staff to do this. Conducting self-audits or commissioning external audits can help verify whether those procedures are being followed correctly or not.
You can report any concerns you have about facilitated self-selection of P-Medicines to the GPhC using our online concerns form. Please make sure you have details of the pharmacy, the date (or approximate date) that the incident happened, details of the incident – such as the place where the incident happened, what you feel was wrong, and what happened as a result and details of anyone else you have reported the concern to. Further details about submitting a concern are available on the GPhC website.
Pharmacy support staff have an important role in the supply of P-Medicines, including advising on the use of these medicines. Standard 2.2 of the GPhC’s standards for registered pharmacies states that pharmacy support staff involved in the sale or supply of P-Medicines are required to have the appropriate skills, qualifications and competence for their role and the tasks they carry out, or to be working under the supervision of another person (either a registrant or another appropriately qualified or experienced individual) while they are in training.
Making sure the supply of P-Medicines is safe and effective is a vital pharmacy service: if this role is not performed well, it can pose a risk to the safety of people using the pharmacy, and the ability of the whole pharmacy team to meet the GPhC’s standards for registered pharmacies. It is therefore important that all pharmacy support staff have the appropriate education and training for this role to enable them to be competent in the supply of P-Medicines that are on open display, and to empower them to safeguard the health, safety and wellbeing of patients and the public.
You should always advise your insurers of any changes you make to the operation of your pharmacy which may affect the level of risk involved in providing your services.
That will depend upon the size and layout of your pharmacy, and the location of the tills. You must be satisfied that you can effectively supervise the sales, and that your team members can easily seek your advice or assistance if necessary. If your premises are partially registered, then you must ensure the sales can only be completed at tills within the registered part of your premises.
You should carefully consider this scenario in your risk assessment and ensure that you have provided your team with adequate training to deal with it. You should have clear procedures for your staff to follow and be satisfied that they understand how to carry them out.
Maintaining confidentiality is a vital part of the relationship between a pharmacy and the person seeking care. A pharmacy would be expected to take steps to protect people’s confidentiality irrespective of the storage of its P-Medicines. Pharmacies can do this by ensuring appropriate staff training on the importance of protecting people’s confidentiality and various other means such as offering the use of a consultation room.
Any risk assessment that has been carried out should identify where things might go wrong and specify what action has been taken to mitigate or minimise each individual risk that has been identified. You must make sure that you are satisfied that the risks in your pharmacy have been mitigated or minimised in such a way that the pharmacy is compliant with all legal requirements covering the supply of P-Medicines and that any supplies will be made in line with the GPhC’s standards for registered pharmacies.
The legislation (section 220 of the Human Medicines Regulations 2012) refers to sales of these medicines being made by or under the supervision of a pharmacist. Self-selection is not specifically excluded within the legislation.
Self-selection of P-Medicines may require the pharmacy team to undergo additional training to manage inappropriate requests. For example, they may require some communication skills training to deal with the various scenarios that may arise if a sale is refused because a self-selected medicine is deemed to be unsuitable.
All pharmacy team members involved in the sale of P-Medicines need to have completed the appropriate training to allow them to complete sales appropriately and safely.
Pharmacies will be expected to implement provisions to allow only appropriately trained individuals to be involved in the process of the sales of P-Medicines. For example, restricting sales of P-Medicines to specific tills that only trained team members can use to authorise sales.
All staff should have a clear understanding of what they can and cannot do.
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