All pharmacies in Great Britain, including those providing services via the internet, must be registered with us and meet our standards for registered pharmacies.
Our guidance for registered pharmacies providing pharmacy services at a distance, including on the internet is designed mainly to support pharmacy owners and Superintendent Pharmacists in understanding and meeting our standards. The guidance explains what we expect them to consider before deciding whether any parts of their pharmacy service can to be provided safely and effectively at a distance (including on the internet), rather than in the traditional face-to-face way. The guidance also applies to everyone in the team including managers with delegated responsibility, the Responsible Pharmacist and any pharmacists prescribing ‘at a distance’.
Providing pharmacy services online
Our guidance explains what pharmacy owners should consider before providing services at a distance, including on the internet.
Here we answer some of your most frequently asked questions about our guidance on providing pharmacy services online.
Our guidance puts in place extra safeguards to help make sure that people only receive medicines that are clinically appropriate for them. Examples of medicines that require extra safeguards include:
medicines liable to misuse
antimicrobials
medicines which have a higher risk of fatality or serious harm if taken in overdose
medicines and long-term conditions that require ongoing monitoring or management
medicines where there needs to be a physical examination of the person to support a safe prescribing decision
medicines labelled with a black triangle (▼ or ▼*)
medicines used for weight management
The safeguards include making sure that the prescriber does not base prescribing decisions on the information provided in a questionnaire alone. Instead, the prescriber has to independently verify the information the person provides, either through timely two-way communication with the person, accessing the person’s clinical records, or contacting the person’s GP, their regular prescriber, or a third-party provider.
The safeguards also include making sure the prescriber proactively shares all relevant information about the prescription with the person’s regular prescriber after seeking the person’s consent.
In the case of medicines for weight-management, the prescriber has to independently verify the person’s weight, height and/or body mass index. This helps to increase the reliability of the information they receive, supporting safer decision making and ensuring that the supply is appropriate for the person.
In the case of medicines liable to abuse, or medicines which have a higher risk of fatality or serious harm if taken in overdose, appropriate steps are to be taken to confirm that the medicine is appropriate for the person, before making a supply. This would involve contacting the person's regular prescriber or checking the person’s clinical records, with the person’s consent to confirm that the prescription is appropriate, and that the necessary monitoring is in place.
In cases where the person doesn’t have a regular prescriber, such as a GP, or if there is no consent to share information, the prescriber should then decide whether it is safe to prescribe. They will need to think about the person’s best interests and carry out an individual risk-based assessment about whether they can prescribe safely. They should consider whether supplying treatment outweighs the risks, taking into account whether the person would be at risk of death or serious harm if they were also getting medicines from other sources. The prescriber should make a clear, comprehensive record, at the time they make the decision, setting out their justification for prescribing, or not prescribing. If the decision is made not to prescribe, the person should be directed to an appropriate care provider so that they can be appropriately assessed. Examples include, but are not limited to, an out-of-hours service, a local walk-in centre or urgent care.
We expect all online pharmacies to have systems in place to carry out an identity check appropriate for the medicine being supplied.
During a risk assessment, the pharmacy owner and the Superintendent Pharmacist, if there is one, should gather evidence about the risks for each individual service, medicine and medical device before providing that service. Through this careful and thorough look at the individual medicine, they should determine what level of identity checking will be appropriate.
We don’t specify a particular technical solution for checking a person's identity. Instead, there should be a robust process in place to carry out checks appropriate to the medication they’re supplying.
There are several different ways to check a person's identity. This can include using an external credit reference database or a specific identity-checking service using photo ID verification.
If a pharmacy works with an online prescribing service or prescriber, they should also have evidence to assure themselves that the prescriber has robust processes to check the identity of the person, to make sure the medicines prescribed go to the right person.
We expect the pharmacy’s digital platform and the platforms of associated companies to be arranged so that a person has an appropriate consultation with a prescriber before any supply of a prescription only medicine (POM) is made.
The digital platform can allow people to give their preferred choice of medicine, for example a preferred brand or formulation, before the consultation. However, our guidance makes it clear that the decisions about treatment are for both the prescriber and the person to consider together during the consultation.
We are clear in the guidance that the pharmacy owner and Superintendent Pharmacist, if there is one, must make sure that there are robust processes in place within the online pharmacy to:
carry out identity checks on people obtaining medicines, appropriate for the medicines being supplied
identify requests for medicines that are inappropriate, including multiple orders to the same address, a person using multiple accounts to make orders, orders using the same payment details or inappropriate combinations of medicines.
Working with prescribers who aren’t appropriately registered with the relevant UK professional regulator, and with prescribing services not based in the UK, creates significant extra risks for patients and the public.
If pharmacy owners and Superintendent Pharmacists decide to work with prescribers or prescribing services operating outside the UK, they need to make sure that:
they actively manage the extra risks that this may create and can show that this is the case
the prescriber is registered with the relevant professional regulator in the country they are based in (that is, where the prescription is issued), and they can lawfully issue prescriptions online to people in the UK
and that the prescriber is working within national prescribing guidelines for the UK and good practice guidance
they have sufficient indemnity in place to cover their service that uses prescribers or prescribing services based outside the UK, and pharmacy staff supplying medicines against prescriptions issued by these prescribers or prescribing services
any cross-border arrangements in the service design meet the legal requirements that apply in all parts of the UK the business operates in
Our inspectors will be looking in detail at how the pharmacy is managing potential risks during inspections and we will act where necessary.
Pharmacy owners and Superintendent Pharmacists, are expected to always follow the guidance, including when supplying to people outside the UK.
If pharmacies sell or supply medicines to people in other countries, they must keep to any other laws that apply. Countries have different restrictions, and some don’t allow the online supply of medicines at all.
It’s the owner’s responsibility to make sure the medicine they supply has the marketing authorisation needed for it in the country of destination.
The guidance is designed mainly to support pharmacy owners and Superintendent Pharmacists in understanding and meeting our standards. Not meeting our standards could result in us taking enforcement action. This could be against the pharmacy, the pharmacy owner, the Superintendent Pharmacist, or all three. We could also investigate the fitness to practise of all the pharmacy professionals involved.
There should always be a means to allow two-way communication between the person and the prescriber for all online prescribing, so both the person and the prescriber can ask questions and get further information.
When selecting what is the most appropriate method of consultation to use, decide which method of consultation is best suited to get the information needed to deliver safe and effective care. Consider:
if the person has a potentially serious, high-risk condition where there is a need for a physical examination or other assessments
if there is a need for a diagnostic test before prescribing a medication
whether timely two-way communication can be established; whether it meets the communication needs of the person, and gives the pharmacy professional and the person the chance to ask questions to get the information they both need
If a method that allows timely two-way communication is not available to both the prescriber and the person, the person should be directed to an appropriate care provider so that they can be appropriately assessed.
Our guidance says “Decide which method of consultation is best suited to get the information needed to deliver safe and effective care. This includes deciding which method is best suited to deal with any specific requirements, or concern meets the communication needs of the person”. It then states to decide whether the consultation method:
meets the communication needs of the person
gives the pharmacy professional the chance to ask questions to get the information they need to make a proper assessment of the person, and
gives the person the chance to ask any questions that they have.
Methods of two-way communication could include a video consultation, in-person consultation, email, live chat or phone call.
Using an automated or AI ‘chatbot’, or similar tools that do not involve people in real time would not be appropriate, as using a bot alone would not always meet the communication and other needs of people.
Through our inspections and investigations, we’ve seen significant risks to patient safety when online questionnaires have been the only method of consultation used with the person, and when the information provided by the person isn’t verified by the prescriber. These risks include people providing false information to obtain medicines that are clinically inappropriate for them.
Our guidance requires that the prescriber does not base prescribing decisions on the information provided in a questionnaire alone. Instead, the prescriber independently verifies the information the person provides, and gets the information they need to support their prescribing decisions. This could be through timely two-way communication with the person, accessing the person’s clinical records, contacting the person’s GP, their regular prescriber, or a third-party provider.
For example, to provide medicines for weight-management, the prescriber has to independently verify the person’s weight, height and/or body mass index. This helps to increase the reliability of the information that the prescriber receives, and supports safer decision making and ensures that the supply is appropriate for the person.
If the prescriber cannot independently verify the information the person provides or get the information they need, the person should be directed to an appropriate care provider so that they can be properly assessed.
By ‘independently’ we mean that the prescriber does not rely on the information provided to them by the person, but uses a different way to verify the information provided.
We expect pharmacy owners and superintendents to read our guidance and implement any necessary changes to their services at the earliest opportunity.
We would expect pharmacies to engage with the new guidance and actively take steps to make progress in actioning changes. We are aware that not all changes can be immediately implemented.
We will take a proportionate approach on inspection and carefully consider each case individually.
Our guidance is designed mainly to support pharmacy owners and Superintendent Pharmacists in understanding and meeting our standards. If an online prescribing service is regulated by another healthcare regulator, then that regulator is responsible for regulating their activities. The pharmacy owner and the Superintendent Pharmacist are still responsible for providing the pharmacy service safely and effectively even if there are arrangements with a third party or if part of the pharmacy service is sub-contracted to a third party. Pharmacies who choose to work with third party providers which are regulated by other healthcare regulators to provide part of their service, will need to undertake their due diligence and consider specific issues of which examples are outlined on page 10 of our guidance.
The Medicines and Healthcare Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK. One of their statutory roles is to regulate the advertising and promotion of medicines in the UK.
The guidance set out in the MHRA’s Blue Guide, Advertising and promotion of medicines in the UK, describes the UK legislation on the advertising of medicines and the role of MHRA and the wider regulatory framework. It provides advice on how to comply with the legislation on advertising to healthcare professionals and the public in a wide range of settings to safeguard the public from the effects of misleading advertising and promotion of medicines.
The Advertising Standards Authority (ASA) is the UK’s independent regulator of advertising across all media. They make sure advertising rules are followed.
Working with third party service providers which aren’t registered with a relevant UK professional regulator, can create significant extra risks for the pharmacy team, patients and the public.
Pharmacy owners and superintendents should carry out appropriate risk assessments prior to providing a service which take account of the systems and processes put in place by the third party to ensure any risks to patients are mitigated as far as possible. To reduce risks we expect clear, written, service level agreements between the pharmacy and any third-party provider(s) to be in place. This should include who is responsible for what, including patient monitoring, and clear lines of escalation if the patient (or their carer) has a problem or question.
We expect pharmacy owners and superintendent pharmacists to ensure that if they choose to work with a third-party prescribing service, that the provider is registered with the appropriate regulator, in the country where they are based, for the activities they carry out.
This may include registration with:
the Care Quality Commission (CQC)
Healthcare Improvement Scotland (HIS)
the Regulation and Quality Improvement Authority (RQIA)
Healthcare Inspectorate Wales (HIW)
General Pharmaceutical Council (GPhC)
If the third-party's services are registered with another regulator for example, CQC, then that regulator has responsibility for regulating the service’s activities.
Pharmacies should not work with online providers who avoid or try to avoid appropriate UK regulation.
Pharmacy owners and superintendent pharmacists should:
carry out their due diligence and ensure they understand the business model of any contractor or provider they choose to work with
They should also check that healthcare professionals working or contracted to provide prescribing services for third party providers are registered with an appropriate regulator (for example with the General Medical Council, Nursing and Midwifery Council or GPhC) and have no relevant restrictions on their practice.
check that the third-party service is registered with the relevant UK regulators as listed above.
they should ensure that the third-party provider, prescriber and/or clinic address is registered for the specific activities which they claim to be delivering. For example, a third-party service may be registered by a regulator for a specific service such as an aesthetic service, but the third-party service may also be providing a general prescribing service and not be regulated for this activity.
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